23 jobs found in lakewood

NAPA Auto Parts We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, protected veteran status, or any other characteristic protected by law. Category: Driver Job Id: 270941 Brand: NAPA Auto Parts Location: Lakewood, CO Major Market: CO – Denver Date Posted: October 14, 2019 Job Description As a Full -Time Delivery Driver for NAPA, your focus is on getting the right parts to the right people at the right time. Our deliveries are the heartbeat of our Wholesale business, and our Drivers are critical to our success. NAPA delivers quality experience not only to our customers but to our employees, in the form of career growth opportunities, great benefits including 401(k), and a parts discount! Responsibilities Passion for developing relationships with our customers Care and responsiveness while driving and delivering our parts Ability to work independently while engaging with customers as the face of NAPA throughout the day Building long-term relationships with the customers you deliver to Qualifications The ideal Full -Time NAPA Delivery Driver: Minimum 18 years of age Agility to bend to floor-level shelves and reach to upper shelves (eight feet) with use of stool or ladder when necessary Stamina to stand and walk for entire work shift Strength to lift 60 lbs of merchandise Utilizing both manual and automatic transmission vehicles Handling cash charge transactions correctly and core/part returns appropriately Maintaining a distribution log or tracking system to record all deliveries/pickups made Inspecting, protecting and maintaining company assets, merchandise, vehicles, building and people Clear speaking and attentive listening skills Driving throughout the metropolitan area using maps and directions Flexibility in schedule including evenings, weekends and holidays Valid Driver's License 270941 GPC believes the fair and equitable treatment of employees, customers, suppliers and other persons is critical to fulfilling its vision and goals. GPC conducts its business without regard to sex, race, creed, color, religion, marital status, national origin, age, pregnancy, sexual orientation, gender identity, genetic information, disability, military status, status as a veteran, or any other protected characteristic. GPC's policy is to recruit, hire, train, promote, assign, transfer and terminate employees based on their own ability, achievement, experience and conduct and other legitimate business reasons PI114558829

NAPA Auto Parts We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, protected veteran status, or any other characteristic protected by law. Category: Retail Job Id: 270943 Brand: NAPA Auto Parts Location: Lakewood, CO Major Market: CO – Denver Date Posted: October 14, 2019 NAPA is a Parts Store and So much more! We are driven to have the best people on our team to get the right parts to the right place at the right time. The Role: This is the ideal role for a person who truly cares about providing outstanding customer care and interactions with everyone who they come in contact with! As an Automotive Counter Parts Sales person, you are looked at as the "face of the retail store" and the go to person as soon as our customers enter our retail stores. This is the right opportunity for you if you: * Genuinely enjoy helping our retail and wholesale customers with their auto parts and service questions. * Have gained your parts experience by working the automotive industry or have gained your experience tinkering with/repairing cars & trucks through the years * You are willing to learn all things automotive if you don't have the background in automotive parts. * Want to join a team where you can learn and grow your career - the opportunities are endless! A Day in the life: * Provide auto parts answers and solutions for our retail and wholesale customers * Bring customer focus and high energy to our fast-paced stores * Welcome retail customers into our retail stores and engage to provide a positive consumer experience * Use technology (computer), cash register, telephone, and paper catalog system * Use your parts knowledge to assist other NAPA team members answer questions for customers What you'll need: * Previous experience in a parts store or automotive industry or at least a willingness to learn all things auto parts. * High School Diploma or GED. Technical or Trade school courses or degree. * Excellent verbal and written communication skills * Love fast paced retail environments And if you have this, even better: * Background and/or passion for automotive industry, heavy equipment, farm industry, diesel, marine, or dealership. * Experience in a parts store, auction, retail store, auto body/collision * Knowledge of cataloging AND/OR inventory management systems, a plus * Entirely customer-centric (external/internal) * ASE Certifications * NAPA Know How * Past experience working for an Independently owned parts store Why NAPA may just be the right place for you: * Outstanding health benefits and 401K * Stable company. Fortune 200 with a "family" feel * Company Culture that works hard, yet takes care of employees * Opportunity for accessing multiple career paths, ongoing development, with support from leaders and your team Additional information for you: NAPA has great careers for people with all backgrounds and interests. So if after reading this, you don't think that it is the perfect fit for you, check out a few of our cool day in the life career videos from our awesome employees by visiting NAPAautojobs.com. While on our career site, check out the list of the many other diverse roles we have as well. 270943 GPC believes the fair and equitable treatment of employees, customers, suppliers and other persons is critical to fulfilling its vision and goals. GPC conducts its business without regard to sex, race, creed, color, religion, marital status, national origin, age, pregnancy, sexual orientation, gender identity, genetic information, disability, military status, status as a veteran, or any other protected characteristic. GPC's policy is to recruit, hire, train, promote, assign, transfer and terminate employees based on their own ability, achievement, experience and conduct and other legitimate business reasons PI114558847

Overview The Forklift Operator reports to the warehouse management and is responsible for various duties in maintaining warehouse, shipping, and receiving areas. This is a 2nd shift position Responsibilities Read and comprehend warehouse procedures. Pull materials for production lines in compliance with cGMP's. Unload and load trucks. Check materials delivered according to SOP. Transport materials between various buildings using company truck. Log and deliver non-inventory express packages. Put away materials that are properly identified in compliance with cGMP's. Maintain and operate forklift and material handling equipment safely. Fill out forklift log books. Attend any type of classes for operation and safety of the forklifts. Wrap finished goods for shipment. Assist with Cycle Counts. Maintain compliance with SOP's and cGMP's. Follow instructions given by the Supervisor and Materials Coordinator Exemplify the DPT Core Values of Integrity, Dignity, Perseverance and Trust Other duties as assigned. Qualifications Entry level. Prefer at least 2 years of relevant experience in the pharmaceutical industry, and previous forklift certification.A minimum of 3 years of relevant experience in the pharmaceutical industry PI114486953

Overview Quality Assurance Inspectors work "hands-on" on the production floor, inspecting packaging, labeling and finished products to ensure products comply with Company policies and standard operating procedures (SOPs) and Good Manufacturing Practices (GMP) requirements. Quality Assurance Inspectors perform sampling, inspection and physical testing of packaging components and raw materials. They issue and control the labels and packaging inserts and are responsible for following all quality assurance procedures and ensuring all documentation meets cGMP standards. Responsibilities • Perform Quality Assurance tasks including production line clearances, sampling, inspections, and quality attributes testing designed • Monitor product quality through the performance of required visual testing. • Perform routine line clearances/in-process inspections on the packaging lines and compounding suites. • Ensure routine compliance of day to day activities on the compounding and packaging areas; working with operations personnel to achieve compliance. • Monitor packaging and compounding to ensure that batch documentation requirements and SOPs are being followed. • Review the required paperwork for accuracy and compliance, both on line and upon completion of the activity. • Ability to gown to Grade C standards and perform quality inspection inside cleanroom areas. • Report non-conformances associated with components, in-process materials, finished products, etc. that may be identified at any stage of production or storage. • Collect representative samples for testing and retention, and ensure all relevant paperwork is complete. Submit samples/resamples to laboratory in a timely fashion to meet production needs. • Inspect and approve packaging components, manufacturing/packaging rooms, lines and equipment prior to use. • Sample in-process items and finished products. Perform required inspections and testing of in-process items and finished products. • Apply disposition stickers to components, in-process materials and finished products. • Stage label and inserts on production lines, issuing reports and verifying customer and Renaissance part numbers and comparing information to the staging sheet. Return unused labels and inserts or have them destroyed when requested by customer. • Process and distribute samples to other teams (i.e. Quality Control Laboratory) for evaluation and testing, as required. • Review records to confirm accuracy, completeness and GMP compliance. • Ensure all work performed is documented accurately and completely in batch records, forms, logs and other documents. • Provide training to QA and Operations staff on proper documentation and inspection procedures. • Maintain a clean and safe environment in compliance with State and Federal regulatory guidelines. • Ability to work with computer based systems and equipment. • Perform other duties and responsibilities as assigned. Qualifications High School diploma or GED and a minimum of 3 years of relevant experience or equivalent combination of education and experience. PI114486950

Overview The Gown Qualified Technical Operator will operate equipment to fill and seal product into containers within a controlled environment and maintain areas to a controlled status in accordance with all operational records, SOPs and cGMP requirements. The Gown Qualified Technical Operator (GQTO) is responsible for the full spectrum of job duties currently held by Gown Qualified Operators. In addition, the GQTO will be responsible for environmental monitoring of the controlled areas, coordinating assigned tasks with team members and aseptic setups of rooms, product contact trains and component trains in the filling areas. Responsibilities • Exemplify Renaissance Core Values • Performs job functions in conformance to current Good Manufacturing Practices (cGMP) and Standard Operating Procedures (SOP) specifically associated with assigned tasks and generally as a Renaissance employee. o Maintains qualifications/proficiency through continual training and monitoring. • Performs in-process sampling such as weight checks, stopper height checks, machine challenges, etc. o Following the specifications of the filling record, packaging record, or protocol. • Regularly work within the controlled areas (classified and non-classified) o Properly gown in conformance to the approved gowning procedures associated with the classification being entered. o Exhibit good aseptic technique while working in assigned controlled area. • Maintains control of environmentally controlled areas through cleaning and sanitization of the controlled environments on a regular basis. o This includes sanitizing equipment/machine surfaces, ceiling, walls, floors, etc. o Routine gowning o Component and material transfer. • Maintain complete and accurate documentation of assigned job functions in accordance to Good Documentation Practices (GDP). • Operate equipment within assigned controlled non-classified and controlled classified areas. o Including but limited to automated and manual washers, tunnels, fillers, cartoners (non-controlled) and labelers (non-controlled areas). o Operate equipment in non-controlled areas as needed. o Assist others through training and mentoring. o Make minor adjustments (fill weights, torque, etc.) as needed to maintain process control. • Monitor process controls regularly and report any abnormalities observed to area and/or quality supervision. • Represents Operations as the process owner. o Reports any observation made that can potentially harm the product, process, or business objective. o Provides guidance to those observed not following procedures. o Reports any safety concerns to area supervision and/or EH&S. o Share operational knowledge with peers, new-hires, temporary staff members, and newly-appointed operators, as needed, to maintain efficiencies and cGMP compliance. o Provides ideas for process improvements. • Participate in team efforts to improve our work environment, product quality, efficiencies, and other initiatives identified as being beneficial to our business. • Performs monitoring of processes within controlled areas to ensure control is maintained in these critical areas. o Performs personnel monitoring within the controlled areas. o Performs viable and non-viable monitoring during static and dynamic conditions. o Obtains all supplies required to monitor the controlled areas. o Delivers samples to the Microbiology Lab for further evaluation. • Coordinates assigned tasks with team members as directed by reporting supervisor. o Coordinates cleaning/sanitization activities. o Coordinates job rotation. o Coordinates filling activities. • Performs aseptic setups of product and non-product contact parts. o Filling equipment in sterile and non-sterile processes. Qualifications One of the following 3 scenarios are required to be considered for the role of a GQTO: 3 years of relevant experience + High School Diploma 2 years of relevant experience + Associate's Degree 1 year of relevant experience + Bachelor's Degree Note: Personnel with experience must not have been disqualified from the aseptic areas in the past 12 months. PI114486952

Overview The Scientist I, R&D supports validation activities of analytical methods and method transfer from R&D to QC labs for new pharmaceutical projects. Applying a working knowledge of Method Validation theories, practices and concepts, the incumbent works under the direct supervision of more senior R&D scientists to execute validation activities. Insure Standard Operating Procedures and protocols are maintained and applied. Responsibilities • Under the supervision of The R&D Manager or a Senior Scientist, support validation activities of analytical methods and method transfer from R&D to QC labs as per the current SOPs, ICH and FDA guidelines. • Conduct routine and non-routine laboratory analyses such as finished product testing, stability testing, and manufacturing in-process testing of R&D /engineering batches which require critical levels of accuracy. • Use analytical techniques like HPLC/UHPLC, and GC using empower software, Karl Fisher, UV spectrophotometer etc., that is used in analytical development activities • Write standard methods of analysis. • Write and review analytical test methods, reports and protocols. • Operate all laboratory analytical instrumentation and perform troubleshooting and calibration of laboratory equipment as needed. • Perform assigned various tasks which are needed to maintain the laboratory. Such tasks may include ordering lab supplies, calibrating instruments, cleaning glasswares and Hazmat duties. • Manage time effectively to complete assignments in an expected time frame. • Document all experimental work neatly and correctly in a lab notebook in accordance with Standard Operating Procedures. • Review lab testing results and notebooks to ensure accurate documentation. • Ensure proper training before performing any tests and maintain an up to date training record related to all job functions and GXP requirements. • Maintain current knowledge of relevant Quality System Regulations and other regulatory requirements related to research and development (product development, design and safety) to ensure compliance in all research, data collection and reporting activities. • Maintain quality checks on safety of the Lab, including biohazards and insure maintenance of the facilities according to Good Laboratory Practices. Communications • Compile data and interpret any out of trend/specifications against predetermined validation criteria • Effectively interact with other scientists, project managers and colleagues from numerous functions. Qualifications Bachelor's degree in Pharmaceutical Sciences, Chemistry, or similar degree and relevant experience in the pharmaceutical industry is preferred. 3-5 Years experience required PI114456457

Overview The Quality Compliance Associate will support Quality Compliance objectives to ensure compliance to state, federal and other requirements. Responsibilities Plan, conduct and document internal audits. Evaluate findings and report these to the respective department and upper management. Assure implementation of any resulting corrective action plans. Use the internal audit program to assess the level of DPT's compliance with applicable cGMP, QSR and pertinent standard operating procedures (SOPs). Plan, conduct and document external audits (Raw Materials, Contract Laboratory, Sterilization facilities, etc.). Evaluate findings and report these to the respective companies and Renaissance management. Assure implementation of any resulting corrective action plans. Use the internal audit program to assess the level of Renaissance's compliance with applicable cGMP, QSR and pertinent standard operating procedures (SOPs). Assist with on-site cGMP audits performed by, or on behalf of, clients and potential clients. Represent Renaissance Quality Systems and facilitate interactions between clients and Renaissance personnel during the audit. Assist with management of observations and corrective actions in Trackwise. Manage and prepare client submission documents retrieved from supporting departments and assist in responding to deficiency letters received from agency. Represent Lakewood Quality Compliance on client conference calls for submission readiness and support. Support upper management as necessary in preparation for, during and following regulatory agency inspections. Maintain knowledge of cGMP (US/EU) and company operating procedures and policies. Performs other duties as assigned. Is able to travel a minimum of 30% Qualifications Bachelor's (B.S.) degree is required. A minimum of four years related experience and/or training is required. ASQ CQA & or RAC certification preferably PI114239507

These positions will work 4 10 hour shifts: Wed - Sat or Sun - Wed. Scientist I, QC Overview Provide technical support for routine testing activities and conduct physical and chemical analysis of samples, products and materials. Primarily responsible for technical transfer and validation of methods to support quality control testing of products and materials. Identify basic technical problems, atypical test results or methodology malfunctions and assist in the investigation to correct them. Other important duties include ensuring notebooks and reports are in compliance with regulatory guidelines, completing projects within time limits and budgetary constraints, performing mathematical calculations, interpreting results, recording observations and responding to and assisting in audits and investigations. Participate in departmental training and provide guidance to junior staff members. Scientist I, QC Responsibilities • Accurately generate data using validated test methods and SOPs in a cGMP environment. • Demonstrate technical competence in the use of wet chemical techniques and instrumentation pertinent to the job including: • IR Infra-Red Spectroscopy • UV/Vis Ultra Violet/Visible Spectroscopy • GC Gas Chromatography • HPLC High Pressure Liquid Chromatography • UPLC Ultra High Pressure Liquid Chromatography • AA Atomic Absorption Spectroscopy • Dissolution apparatus • Compendial testing (USP EP, FCC) - ex. Monograph assay, limits tests, chemical and physical tests • Responsible for analyzing data, maintaining accurate and detailed written records and notebooks and thoroughly reviewing lab notebooks ensuring compliance to test methods and specifications. • Ability to work in a team environment. • Train other Scientists and Lab Technicians in various methodologies. • Maintain training logs to comply with current SOP requirements. • Ensuring safety regulations are adhered to in the laboratory.

Overview The Manufacturing Process Operator reports to the Production Supervisor through the line leader. This person is responsible for safely operating all equipment on any packaging line in controlled and non-controlled areas outside the sterile cores. This person will also be responsible for the inspection of filled product under controlled conditions. Responsibilities Exemplify Renaissance Core Values Run equipment as per the validated machine settings. Gown and work within controlled non-sterile areas. (i.e. Scrubs, Head Cover, Facial Hair Cover (if applicable), shoe covers, gloves, Tyvek hood, coveralls, boots and safety goggles) Inspect micro-suppository for the presence of the product, voids, length, broken suppositories. Maintains qualifications/proficiency through continual training and monitoring. Document machine related downtime as required. Ensure only acceptable product is allowed downstream. Communicate mechanical issues or process deviation to Supervisor, Line Leader and mechanical staff. Maintain complete and accurate documentation of assigned job functions in accordance to Good Documentation Practices (GDP). Make minor mechanical adjustments. Responsible for cleaning equipment and the area around the equipment. Follow directions with minimum Supervision and complete all paperwork required Keep an accurate record of component and product waste. Maintain a good attendance record. Other duties as assigned Ensure that in the performance of daily activities, that all applicable cGMP are followed. Immediately report to the Line Leader, Quality Assurance or the Production Supervisor any behavior or practice that is not cGMP compliant. Maintain knowledge of cGMP by attending required training sessions Qualifications High school degree, with aEntry level - no experience required. Prefer at least 2 years of relevant experience in the pharmaceutical industry minimum of 3 years of relevant experience; or equivalent combination of advanced education (ie, coursework in Life Sciences) and experience. Ability to pass basic skills test. Must have 20/20 eyesight (with or without corrective lens) and able to distinguish colors for the inspection process and be capable of consistently identifying small particles of foreign material. Education: SAMPLE JD TEXT: Bachelor's Degree in related field required with a minimum of ## years of relevant experience in the pharmaceutical industry or equivalent combination of education and experience. Master's Degree preferred. PI114128666

Scientist I Overview The Scientist I will provide technical support for routine testing activities and conduct physical and chemical analysis of samples, products and materials. Primarily responsible for technical transfer and validation of methods to support quality control testing of products and materials. Identify basic technical problems, atypical test results or methodology malfunctions and assist in the investigation to correct them. Other important duties include ensuring notebooks and reports are in compliance with regulatory guidelines, completing projects within time limits and budgetary constraints, performing mathematical calculations, interpreting results, recording observations and responding to and assisting in audits and investigations. Participate in departmental training and provide guidance to junior staff members. This is a Wed-Saturday 10 hour/4 day 1st shift position Scientist I Responsibilities • Accurately generate data using validated test methods and SOPs in a cGMP environment. • Demonstrate technical competence in the use of wet chemical techniques and instrumentation pertinent to the job including: • IR Infra-Red Spectroscopy • UV/Vis Ultra Violet/Visible Spectroscopy • GC Gas Chromatography • HPLC High Pressure Liquid Chromatography • UPLC Ultra High Pressure Liquid Chromatography • AA Atomic Absorption Spectroscopy • Dissolution apparatus • Compendial testing (USP EP, FCC) - ex. Monograph assay, limits tests, chemical and physical tests • Responsible for analyzing data, maintaining accurate and detailed written records and notebooks and thoroughly reviewing lab notebooks ensuring compliance to test methods and specifications. • Ability to work in a team environment. • Train other Scientists and Lab Technicians in various methodologies. • Maintain training logs to comply with current SOP requirements. • Ensuring safety regulations are adhered to in the laboratory. Scientist I Qualifications Bachelor's Degree (BA or BS) in Chemistry, Biology or related science required with a minimum of 5 years of relevant experience in the pharmaceutical industry; or equivalent combination of education and experience. PI114128668

Overview The Project Coordinator/Technical Reviewer directly supports in the daily management of multiple projects and data for our healthcare partners. Specific responsibilities include the creation and maintenance of laboratory timelines, documentation review/approval (such as chromatography, protocols, and applicable change controls), and writing notifications and deviations. Bench testing may be requested. As the laboratory point of contact with the Project Managers group, the individual needs to maintain strong professional relationships while setting realistic expectations and ensuring timely communication. Responsibilities • Participate in internal, cross-functional teams to ensure project milestones are met as contracted with our healthcare partners. • Accurately review data using validated test methods and SOPs in a cGMP environment. • Demonstrate technical competence in the data review that is related analytical data integration. Review methods that is related to use of instrumentation & data processing to the job including, but not limited to: o HPLC High Pressure Liquid Chromatography o UPLC Ultra High Pressure Liquid Chromatography o IR Infra-Red Spectroscopy o Spray Characterization Tests • Gather information and contribute to the writing and review of protocols. • Attend internal and client meetings to provide communication of progress and issues. • Responsible for writing and revising SOP's, investigations, deviations, technical reports, etc. • Support regulatory submission information gathering. • Identify opportunities to improve processes/systems. Perform impact assessments for change controls as required. • Responsible for analyzing data, maintaining accurate and detailed written records and notebooks and thoroughly reviewing lab notebooks ensuring compliance to test methods and specifications. Properly document any changes to laboratory timelines and follow up to ensure approval of same by the client and internal team members. • Perform testing within the lab, when necessary. • Perform other duties and responsibilities as assigned. Qualifications Bachelor's degree required. Master's degree preferred. A minimum of 5 years of HPLC or UPLC experience in pharmaceutical industry required. PI114128672

Overview Assist in the efficient receipt, storage, movement and inventory of items throughout the Warehouse. Responsibilities • Perform several tasks simultaneously. Must be able to organize and prioritize work in order to accomplish tasks assigned. • Picks and stages raw materials/ components as required to support work orders on the production schedule. • Complete material returns and issue materials to orders in ERP system. • Assist with receiving of materials. • Assist with deliveries of materials, Fed Ex shipments and other activities as required. • Assists with shipping of finished goods, samples and other materials as required. • Assist Warehouse Supervisor with the tracking and control of work orders. • Assist with disposals of materials that are rejected and/or authorized to destroy. • Manage MRO cage and orders. • Provide direction to fork truck drivers / provide them with work. Conduct regular cycle counts through ERP system. Maintain compliance with SOPs and GMPs. Maintain warehouse safety, organization, and compliance. Perform other duties as assigned by Supervisor or Manager. Qualifications High School diploma or GED and 0-2 years of relevant experience or equivalent combination of education and experience. PI114128674

Overview This position is primarily responsible for carrying out programs for environmental monitoring of controlled manufacturing environments as per regulated microbial and non-viable parameters. Responsibilities Exemplify Renaissance Core Values Performs job functions in conformance to current Good Manufacturing Practices (cGMP) and Standard Operating Procedures (SOP) specifically associated with assigned tasks and generally as a Renaissance employee. Maintains qualifications/proficiency through continual training and monitoring. Regularly work within the controlled areas (classified) Properly gown in conformance to the approved gowning procedures associated with the classification being entered. Exhibit good aseptic technique while observing an assigned controlled area. Performs scheduling of environmental monitoring for controlled environments per frequency requirements and production schedule. Maintain complete and accurate documentation of assigned job functions in accordance to Good Documentation Practices (GDP). Keeps manufacturing, engineering, and quality management advised as to program status, alert and action conditions or any trends being observed. Monitor aseptic technique of personnel regularly and report any abnormalities observed to area and/or quality supervision. Represents Microbiology as the process owner. Reports any observation made that can potentially harm the product or process. Provides guidance to those observed not following procedures. Reports any safety concerns to area supervision and/or EH&S. Share operational knowledge with peers, new-hires, temporary staff members, as needed, to maintain efficiencies and cGMP compliance. Participate in team efforts to improve our work environment, product quality, efficiencies, and other initiatives identified as being beneficial to our business. Leads in the development of corrective action programs, improvements, and modifications to environmental monitoring programs as required. Performs observation of processes within controlled areas to ensure control is maintained and proper environmental monitoring takes place in these critical areas. Reconciles samples throughout the shift on a visual basis during dynamic operations and also when samples are delivered to the Microbiology Lab to ensure proper sampling occurred. Coordinates assigned tasks with team members as directed by reporting supervisor. Ability to assist with deviation writing or deviation review as applicable for environmental monitoring excursions. Qualifications Requires at least a BS/MS in a scientific discipline. A minimum of 2 years of industry experience, Microbiology preferred. Experience in pharmaceutical or medical device industry where controlled environments were utilized is preferred. Proficient in use of personal computer (MS Word, Excel, Windows, etc.). Possesses good communication and interpersonal skills Education: SAMPLE JD TEXT: Bachelor's Degree in related field required with a minimum of ## years of relevant experience in the pharmaceutical industry or equivalent combination of education and experience. Master's Degree preferred. Required Preferred Education Level High school diploma/ GED One year certificate from college/technical school Two years college education/technical school Bachelor's degree Fifth year college or university program certificate Master's degree Doctoral degree PI114128676

Overview The Quality Systems Specialist is to maintain and coordinate Quality Systems related documents namely deviation reports, change controls and product complaints for compliance with cGMP and company procedures with minimal supervision. To review and write cGMP procedures under supervision. To process changes in analytical methods, test specifications and batch records. To issue effective documents including procedures, forms, reports, and analytical methods. To process changes to the procedures. To report periodic quality metrics and perform trending of data. Responsibilities Review and write deviation reports, change controls, product complaints, and standard operating procedures. Implement new chemical component/packaging component specifications. Interact with other departments to address/review observations. Maintain all quality management systems and provide training where applicable. (i.e. Documentum; Trackwise Complaint; Trackwise Change Control; Trackwise Technical Communication; Trackwise Deviation; Order Tracking; QIS; Stability System - Scientek; DCN; BarTender; Batch Record Issuance; Logbook Issuance; Einfo Tree, Archive) Perform gap analysis of all quality related procedures to ensure there are no gaps present Lead process improvements and projects within the company. Generate work flows for creation, revisions, review, approval and implementation of procedures, form, batch records, and methods using electronic systems as documentation. Issue effective documents including procedures, forms, reports, analytical methods, batch records and logbooks. Ensure documents are effective at all times. Review documents for compliance with company standards for formatting, review, approvals and implementation. Create and maintain procedures for document work flow, document retention, archiving and retrieval. Assist with document retrieval during audits. Coordinate assignment of procedures effective dates with training department. Interact with departments to ensure timely revisions and approvals of the documents. Provide training in Quality Systems to ensure effective use of the systems Trackwise, Documentum, QIS, and DCN. Maintain and report quality metrics and trending of data. Act as administrator of electronic system used for Quality functions. Any other tasks as requested by management. Qualifications Bachelor's degree required or equivalent work experience. Prefer at least 2 years of relevant experience in the pharmaceutical industry and experience with GMP documentation review, Quality Systems, and Health Authority Regulations. PI114128678

Overview This position supervises the daily activities of union and non-union personnel in the compounding, filling and packaging of sterile and specialty pharmaceutical products in compliance with FDA regulations and cGMP guidelines. Responsible for the proper operation of all production activities assigned, such as, scheduling, training, coaching and counseling. This includes but is not limited to: preparing, staffing and operating production lines, interaction with customers, data collection and interpretation, investigation writing, technical report writing, change control, cleaning and environmental monitoring, and safety. Responsibilities • Complete production plan by scheduling and assigning personnel; accomplishing work results; establishing priorities; monitoring progress; revising schedules; resolving problems; reporting results on shift production summaries. • Resolve personnel problems by analyzing data; investigating issues; identifying solutions; recommending action. • Maintain working relationship with the union by following the terms of the collective bargaining agreement. • Maintain working relationship with non-union employees in terms of company policy • Maintain safe and clean work environment by educating and directing personnel on the use of all control points, equipment, and resources; maintaining compliance with established policies and procedures. • Ensure efficient operation of equipment by calling for repairs, facility maintenance requests ; evaluating new equipment and processes. • Contribute to the writing and review of documentation such as SOPs and PRs. • Assure that all pertinent SOPs are being followed and maintain compliance with cGMPs. Confers with and assists personnel under his/her supervision regarding manufacturing opportunities. • Participate in developing department goals, objectives, and systems. • Meet regularly with production personnel to communicate company information and review progress/performance against department goals and action plans. • Responsible for coordinating communication among production shifts. • Participate on internal, cross-functional teams to ensure project milestones are met as contracted with our healthcare partners and be accountable for project results. • Manage and collaborate with all team members regarding operational activities pertaining to the timely and successful execution of all assigned projects. • Develop creative solutions to technical and organizational problems in order to keep projects on schedule. • Review, complete and assure implementation of corrective action plans. • Regularly meet with the Operations Manager to discuss overall project plans, updates, forecasting and potential issues or recommendations. • Identify and lead efforts to improve processes/systems. Conduct and follow up on continuous improvement efforts such as 6S . • Self-develop to be able to move into positions of greater responsibility as opportunities occur. • Perform other duties as required and assigned. Qualifications Bachelor's degree in the Natural Sciences, Engineering or a related degree with a minimum of three (3) years of relevant experience in the pharmaceutical industry in an Operational role required. A minimum of one (1) year as a group lead or other leadership position is preferred. Other leadership background will be considered ie. Military Service or leadership courses . PI114128685

Overview This position is responsible for planning, organizing and controlling Facilities and Critical Utilities Maintenance activities on a daily basis with responsibility for results in terms of costs, methods, and employee management. The incumbent develops and administers schedules and performance requirements for Facilities and Engineering staff to drive continuous improvement and sustainable organizational growth, and acts as an advisor and mentor to direct reports to help meet schedules and/or resolve technical problems. Frequently interacts with suppliers and contractors to improve building, equipment, and processes around the plant. The incumbent interfaces with internal and external stakeholders, Regulatory Compliance, QA, Operations, Planning and Regulatory Agencies (i.e. FDA & EMA). Coordinates and plan maintenance activities accordingly to enhance asset performance. Provide technical support to the entire engineering group and cross-functional teams, as needed. Ensure Standard Operating Procedures and protocols are maintained and adhere to, while ensuring that the group remains in compliance with all regulatory and safety requirements. A brief description of the job's primary purpose or contribution to the department or organization. Assist in the development and implementation of Site's capital plan. Implement and drive a systematic approach for tracking asset reliability and availability in support of production activities, including WFI and USP Water systems, Central Compressed Air System & HVAC. Manage facility related projects, including office space management. Ensure efficient and safe operation of the Lakewood site by providing world class maintenance service in compliance with regulatory requirements. As a member of the Site's Management team, participate in the successful execution of site strategy and policies. Responsibilities Technical • Manage and coordinate facilities related capital projects such as modification of offices and laboratories, as well as construction of new offices and laboratories with responsibility for results in terms of costs, methods, and employees; including the coordination and supervision of outside contractors, vendors and consultants. • Manage the maintenance and sustainability of all critical utilities such as Electrical Systems, WFI and USP Water Systems, Compressed Air System, HVAC Systems, including Boilers and Clean Steam Generators. • Responsible for the maintenance management systems (i.e. BAS and CMMS), including the 24/7 alarm monitoring process. • Responsible for groundskeeping, including landscaping and snow removal. • Manage overall compliance requirement for the group, including change management, deviation management and OSHA regulations. • Coordinate office moves, security system modifications and landscaping activities with responsibility for results in terms of costs, methods, and employees; including the coordination and supervision of outside contractors, vendors and consultants. • Develop, implement and maintain Department policies and procedures. • Lead the expanded use of productivity improvement tools with the group. • Liaison with cross-functional stakeholders to solve specific operating problems and improve Facilities and Critical Utilities maintenance performance. • Provide recommendation and input on technical procedures, techniques and equipment performance. • Responsible for general facility maintenance, Pest Control Management, Janitorial Services, Roof Maintenance and refrigeration systems (i.e. Stability Chambers, Incubators, Refrigerators and Freezers. • Assist in formulating and implementing short and long-range goals for the group; set priorities, assign responsibilities, and drive high performance. • Perform future need forecast through asset life expectancy management and closely monitor building infrastructure to ensure long term sustainability and successful growth of the organization. Communications • Represent the department in interactions with cross-functional stakeholders. • Interface and coordinate with cross-functional team members to successfully achieve the Engineering department's goal and the overall Renaissance organization goals. • Develop, and foster good working relationships with internal and external stakeholders and support initiatives required to continually enhance Renaissance's reputation. • Strengthen inter-departmental relationships at the Manager level. People Management • Primarily responsible for the recruitment, selection and mentoring of employees for the group. • Assure that the Facilities and Engineering staff are properly trained in Standard Operating Procedures (SOPs) and equipment specific requirements. • Plan and schedule work for the group to ensure proper distribution of assignments. • Plan and conduct meetings with direct reports to ensure compliance with established practices, implement new policies and keep employees abreast of current changes and standards. • Monitor employee performance and provide appropriate and timely recognition of their contributions. • Ensure adequate training and development opportunities for Facilities and Engineering employees. • Assist employees in setting career goals and managing career expectations. • Provide guidance as requested regarding hiring, training, promotions, and disciplinary issues for technical personnel. • Understand and comply with all Renaissance safety, environmental and quality practices and procedures as outlined in organizational/departmental guidelines and SOPs as well as applicable federal, state and local regulations including cGMP, ISO, OSHA, GLP and other applicable standards. Qualifications Bachelor's degree in Engineering required along with substantial experience and a proven record of achievement. A minimum of 10 years of relevant experience in the pharmaceutical industry is required, including at least 3 years' experience leading a Facilities or Engineering group. PI114128688

Overview This Process Supervisor supervises the daily activities of union and non-union personnel in the compounding, filling and packaging of sterile and specialty pharmaceutical products in compliance with FDA regulations and cGMP guidelines. Responsible for the proper operation of all production activities assigned, such as, scheduling, training, coaching and counseling. This includes but is not limited to: preparing, staffing and operating production lines, interaction with customers, data collection and interpretation, investigation writing, technical report writing, change control, cleaning and environmental monitoring, and safety. This is a 2nd shift position. Responsibilities • Complete production plan by scheduling and assigning personnel; accomplishing work results; establishing priorities; monitoring progress; revising schedules; resolving problems; reporting results on shift production summaries. • Resolve personnel problems by analyzing data; investigating issues; identifying solutions; recommending action. • Maintain working relationship with the union by following the terms of the collective bargaining agreement. • Maintain working relationship with non-union employees in terms of company policy • Maintain safe and clean work environment by educating and directing personnel on the use of all control points, equipment, and resources; maintaining compliance with established policies and procedures. • Ensure efficient operation of equipment by calling for repairs, facility maintenance requests ; evaluating new equipment and processes. • Contribute to the writing and review of documentation such as SOPs and PRs. • Assure that all pertinent SOPs are being followed and maintain compliance with cGMPs. Confers with and assists personnel under his/her supervision regarding manufacturing opportunities. • Participate in developing department goals, objectives, and systems. • Meet regularly with production personnel to communicate company information and review progress/performance against department goals and action plans. • Responsible for coordinating communication among production shifts. • Participate on internal, cross-functional teams to ensure project milestones are met as contracted with our healthcare partners and be accountable for project results. • Manage and collaborate with all team members regarding operational activities pertaining to the timely and successful execution of all assigned projects. • Develop creative solutions to technical and organizational problems in order to keep projects on schedule. • Review, complete and assure implementation of corrective action plans. • Regularly meet with the Operations Manager to discuss overall project plans, updates, forecasting and potential issues or recommendations. • Identify and lead efforts to improve processes/systems. Conduct and follow up on continuous improvement efforts such as 6S . • Self-develop to be able to move into positions of greater responsibility as opportunities occur. • Perform other duties as required and assigned. Qualifications Bachelor's degree in the Natural Sciences, Engineering or a related degree with a minimum of three (3) years of relevant experience in the pharmaceutical industry in an Operational role required. A minimum of one (1) year as a group lead or other leadership position is preferred. Other leadership background will be considered ie. Military Service or leadership courses . PI114128689

Manufacturing Coordinator Overview This 2nd shift Manufacturing Coordinator position supports the Process Supervisor in the daily activities of union and non-union personnel in the filling and packaging of sterile and specialty pharmaceutical products in compliance with FDA regulations and cGMP guidelines. Responsible for the proper operation of all production activities assigned such as scheduling and training. This includes but is not limited to: preparing, staffing, and operating production line and safety. Manufacturing Coordinator Responsibilities Complete production plan by scheduling and assigning personnel; accomplishing work results; establishing priorities; monitoring progress; resolving problems; reporting results on shift production summaries. Maintain working relationship with the union by following the terms of the collective bargaining agreement. Maintain working relationship with non-union employees in terms of company policy. Maintain safe and clean work environment by educating and directing personnel on the use of all control points, equipment, and resources; maintaining compliance with established policies and procedures. Ensure efficient operation of equipment by calling for repairs, facility maintenance requests; evaluating new equipment and processes. Contribute to the writing and review of documentation such as SOPs and PRs as well as on-line review of batch record documentation. Assure that all pertinent SOPs are being followed and maintain compliance with cGMPs. Responsible for coordinating communication among production shifts. Manage and collaborate with all team members regarding operational activities pertaining to the timely and successful execution of all assigned projects. Regularly meet with the Operations Supervisor to discuss overall project plans, updates, forecasting and potential issues or recommendations. Self-develop to be able to move into positions of greater responsibility as opportunities occur. Perform other duties as required and assigned.

Manufacturing Investigation Lead Overview The purpose of this Manufacturing Investigation Lead position is to serve as the primary writer for the Operations Group to ensure timely and accurate completion of manufacturing investigations, implementation of subsequent corrective actions, and completion of manufacturing change controls. This will be accomplished largely through conducting appropriate root-cause analyses for events and authoring investigations reports related to compounding, filling, inspection, and packaging of sterile and non-sterile pharmaceutical products. Manufacturing Investigation Lead Responsibilities Lead and support prompt and thorough investigations assuring that thorough root cause evaluations are performed in compliance with cGMPs and associated SOPs and ensures timely closure for each investigation as well as follow-up activities. Work with the functional areas to identify the most probable root cause(s) and determine appropriate preventive and corrective actions. Trend and analyze investigation data and address appropriately in cooperation and collaboration with other support functions such as Quality and Engineering. Supports and maintains an environment that fosters communication and teamwork within the Operations Group and other departments. Write technical documents to support operations including SOPs and batch records. Train and mentor less qualified employees in the department. This includes but is not limited to processes, procedures in compliance with established protocols and regulatory guidelines. Maintain current knowledge of cGMPs through appropriate training programs. Share operational knowledge with peers, new-hires, contingency staff members, and newly-appointed operators, as needed, to maintain efficiencies and cGMP compliance. Participate in team efforts to improve our work environment, product quality, efficiencies, and other initiatives identified as being beneficial to our business. Discuss Investigations as required with regulatory agencies or clients ,as required

Sterility Assurance / Validation Associate Overview This Sterility Assurance / Validation Associate position is responsible for generating and executing protocols and generating final reports to support the qualification/validation and re-qualification of various sterilization processes, including: Steam-in-Place, autoclave loads, Vapor Hydrogen Peroxide (VHP) decontamination processes, dry heat sterilization, depyrogenation tunnels, Media fills, EMPQ, and in-process sterilizing filters. The individual will be expected to execute qualification and re-qualification projects with little or no guidance. This will include the scheduling and staffing requests for protocol execution activities in conjunction with Operations and Quality, coordinating testing with internal and external test laboratories, review and tabulation of results, and report generation and tracking and scheduling re-qualification activities. Sterility Assurance / Validation Associate Responsibilities Author qualification and validation protocols and reports Develop Design of Experiments (DOEs), develop statistical sampling plans, assess and approve quality attribute requirements, as well as performing statistical analysis and evaluation of data to draw technical conclusions and make decisions. Execute and analyze Steam-in-Place, Autoclave, Vapor Hydrogen Peroxide (VHP) decontamination, dry heat sterilization, depyrogenation tunnels, bulk product sterilization qualification and re-qualification studies Program, utilize, calibrate, and assemble the Kaye Validator/Thermocouple system. Execute change control requirements for validation Statistical analysis of process capabilities Coordinate related validation projects with Planning, Operations, and other relevant departments as needed Represent the department in interactions with other departments as well as internal and external clients in various settings such as meetings, teleconferences, e-mails, printed reports, etc. Subject Matter Expert (SME) on several sterilization and depyrogenation activities as they relate to the Sterility Assurance/Validation group