20 jobs found in lakewood township

Overview The Director of Ficility Risk Compliance will plan, manage, and provide team leadership to support EHS, Security and DEA Compliance activities at the manufacturing site level. Develop and authorize the implementation of site policies and procedures (SOPs) to assure compliance with government requirements at the Federal, State, and local levels (OSHA, EPA, DOT, NJDEP, OCUA, DEA), and corporate policies, and successfully implementing the same. Work with cross-functional teams to assure alignment of policies and procedures with regulatory, site and security requirements. Must be able to represent Renaissance with customers and regulatory agencies. Responsibilities Site Compliance: ensure site compliance with applicable safety, environmental, wastewater, DEA, and transportation requirements for OSHA, EPA, and DOT regulations. Includes applicable state and local level regulations. Oversight of the DEA compliance program management system . Oversight of site Security Program management system with a focus on maintaining Security Industry standards, best practices and Controlled Substance Security controls. Oversee OSHA Regulatory areas including industrial hygiene, hazard communication, laboratory chemical hygiene plans, respiratory protection, general safety, confined spaces, lock-out tag-out (LOTO), ergonomics, forklift safety, hazardous chemical material handling and storage, behavioral base safety, recordkeeping management, workers compensation, and process safety management. Environmental Regulatory Expertise: Competencies to include Federal. State, and local regulations applicable to storm water, wastewater, solid waste, DEA waste, spill response, and transportation of hazardous materials. Audits: Manage OSHA, EPA, other regulatory bodies, insurance carrier, and Customer audits. This includes preparation for and managing responses to Agencies and Customers audit reports, managing CAPA, and tracking regulatory commitments for the Renaissance site.Budgets: Develop and maintain budgets for the EHS, DEA and Security functions in support of business initiatives and strategies. Customer Interface: Develop and maintain relationships with customers for current and future products. Internal EHS Audits: Develop plans for and manages the preparation of GAP analyses through the execution of internal audits and the development of best management practices (CAPA) to improve performance and compliance with internal policies and procedures. Agency Submissions: Manage or prepare all EPA and OSHA reporting requirements including, but not limited to, OSHA 300 Log, CAA, CWA, RCRA, SPCC, PSM/RMP, Storm water/waste water, Title V, SARA 311, 312, 313, and Hazardous Waste Generator and Air Emissions Inventory. Oversight of all security programs including, but not limited to, access control, security camera control and access, guard staffing/training. Qualifications Bachelor's Degree (BA or BS) required, preferable in Environmental Sciences, Natural Sciences (chemistry or microbiology) or Engineering. Four to ten years related experience and/or training; or equivalent combination of education and experience. Risk management experience preferred. Wide-ranging managerial and leadership skills, including compliance management, and a minimum of 15 years' experience and hands-on work. This experience should encompass applying safety and Environmental regulations and concepts on a pharmaceutical manufacturing operation, as well as DEA regulations and basic Facility Physical Security principles. Thorough knowledge of OSHA, EPA, DOT, and State regulations is required. PI115453802

Were not just another Solar Company Sunnymac is a Master Dealer of SunPowers record-breaking solar panel technology. Unlike most solar companies, we design, engineer, and manufacture every system that bears the SunPower name. We provide the most efficient and reliable solar panels, backed by an industry-leading warranty. We are invested in our local communities, using our expertise to help homeowners save money on their energy costs while simultaneously reducing our local carbon footprint, one installed Solar Power System at a time. We are a member of the Solar Energy Industries Association (SEIA) and NABCEP Certified. We are seeking energetic, outgoing, personable individuals to fill the role of Solar Qualification Specialist - Outside Appointment Setter. This is a Year-Round, Part-Time, Door to Door Canvassing Opportunity. Do you like striking up conversations with strangers? Are you an ambitious go-getter that is hungry for more than just a paycheck? Would you like a career with unlimited growth opportunity? If you answered yes to any of the above, then Sunnymac is interested in you! We are expanding and in need of personable, outgoing, goal-achieving, career-minded individuals with an aptitude for learning, a can-do attitude, and the ability to handle rejection with a smile. Our ideal candidates are progressive self-starters that are tech-savvy, personable and articulate communicators with retail, direct marketing, lead generation, appointment setting, and/or sales experience. A passion for solar and/or the environment is a plus! Job Functions: Traveling to various neighborhoods throughout your workweek, targeting the homes with the potential to go solar. Standing and walking a minimum of four hours per day, five days a week, throughout the year: all seasons, all weather conditions (cold, heat, rain, snow). Striking up conversations with strangers, approaching homeowners, qualifying their home for solar. Scheduling homeowners for an in-home consultation with our Solar Consultants. Working various tabling events: home shows, farmers markets, fairs, festivals, etc. Keeping accurate, detailed, and ongoing records Developing an ongoing pipeline and following up with your leads. Attend all training calls and meetings. Working remotely and independently as part of a larger team. Desired Experience, Knowledge, and Skillsets: D2D or B2B canvassing from any industry experience is a PLUS! Proficient in Google Docs and Microsoft Office Suite Experienced in using CRMs such as Salesforce, Zendesk, HubSpot, Oracle, etc. Any outside Appointment Setting, Lead Generation, and/or Sales experience Proficient in speaking and writing in English, Bilingual a PLUS Previous solar experience is a PLUS Desired Qualities: A professional attitude and appearance Mission and goal-driven: an absolute desire to succeed Self-disciplined and organized: Able to self-motivate and stay on task Have outstanding verbal and written communication skills - be an active listener, articulate, proper enunciation, a conversational communicator , and able to flawlessly write meticulous notes and emails. Persuasive & Influential: able to help others see your point of view and overcome objections Socially Perceptive: able to determine others tone, body language, or reactions and respond appropriately A positive, outgoing, personable, and enthusiastic personality Adaptable, teachable, and willing to learn and keep on learning Additionally: Candidates MUST be available to work a seasonally rotating schedule that includes nights and weekends (20-25 hours a week) Candidates MUST be at least 18 years of age, have own vehicle and insurance, own a tablet or smartphone with a WIFI data plan, and be able to pass a criminal background check Benefits Competitive hourly wage with a generous commission bonus plan. Flexible part-time rotating schedule Fun, but professional, work environment Quarterly & yearly company achievement contests Paid training Direct deposit We are willing to train the right go-getters with a can-do positive attitude! At Sunnymac, we take the environment seriously while keeping our workday fun. We love to connect with others, share our passion for solar, and make a difference in the world one solar installation at a time. Sunnymac began 10-years ago as a solar installation company and has expanded to include a diverse, mission-driven, and goal-oriented sales team. We are a young but stable solar energy company that is still developing our diverse and exciting corporate culture. Come join our team and help to shape our future. APPLY NOW! EOE: Sunnymac Solar is passionate about creating an inclusive and diverse workplace environment. PM19 PI115387620

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 PI114941905

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. PI114941907

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. PI114941908

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 PI114941912

Overview The Scientist II 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 2nd shift position (3:00 pm - 11:30 pm) 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. In the absence of a supervisor or manager oversee the lab schedule and support personnel. . Qualifications Bachelor's Degree (BA or BS) in Chemistry, Biology or related science required. A minimum of 10 years of relevant experience in the pharmaceutical industry; or equivalent combination of education and experience. PI114941913

Overview The Vault Administrator will provide support in day-to-day manufacturing operations to meet the regulatory requirements established by the Drug Enforcement Administration (DEA) and related activities at Renaissance. Responsibilities • Primary responsibility for all "Code" entry on their shift of all controlled substance storage locations and acts as the "Verifier" for transactions at each location. • Will serve as primary for all controlled substance sample transfers between buildings • Will investigate program deviations or discrepancies that directly result from transactions acted as the count "verifier" • Will lead inventory cycle counts for their shift to ensure all Controlled Substance tracking is accurate and complete. • Will assist with investigations resulting from site batch record discrepancies and process deviations. • Assists with preparation of DEA Form 106 Loss/Theft of CS when applicable. • On call response to all emergency vault access such as critical maintenance repairs • Serves as a backup for issuing DEA Form 222s, preparation of import and export applications for CS and other reports as needed. • Assists with documentation and coordination of controlled substance waste disposal. • Assists with regularly scheduled security challenges of controlled substance storage areas. • Provides support during DEA Audits and inspections. • Maintains knowledge of DEA and cGMP regulations as well as company SOPs and policies. • Material Handling (forklift driving) to ensure CS materials are properly located in racks. • Other duties as assigned. Qualifications Bachelor's degree (BA or BS) in related field from an accredited college or university is preferred. 2 years of relevant experience and/or training in the pharmaceutical industry Good computer skills Solid math skills PI114941916

Overview The Metrologisit is responsible for ensuring calibration compliance of all necessary equipment and instruments through understanding of guiding SOPS, instrument OEM manuals, and end user requirements. Supports manufacturing operations (sterile/non-sterile) by ensuring equipment/instrument calibrations are performed at point of use (aseptically as required) when the equipment is available and in a timely manner. Day to day responsibilities will include completing assigned calibration tasks, including paperwork, and troubleshooting basic equipment, implementing fixes as necessary. Responsibilities • Performs maintenance, testing, and calibration on, Scales, gauges, thermometers, manufacturing and laboratory equipment. • Assists in planning calibrations and preparing a list of monthly calibrations using Calibration Manager software. • Assures that monthly calibration requirements are completed compliantly on time, extended, or equipment is tagged out of service if failing or overdue for calibration. • Prepare detailed and accurate documentation of testing that is performed. Timely entering of testing results into Calibration Manager. Initiate and investigate out of specification results using the Trackwise system. • Specifies and requests purchase of components. Knowledge of the PO LN system. • Disassembles and reassembles instruments and equipment, using hand tools, and inspects instruments and equipment for defects. • Communicates and coordinates manufacturing equipment maintenance efforts with Engineering group and others as necessary. • Contacts, schedules and monitors external contractors. Approve paperwork produced by contractors. • Assures that all pertinent SOPs are being followed, maintains compliance with cGMPs and GLP. • Proven ability to work independently and support other technicians to complete assigned tasks in a compliant manner. Ability to work in an Aseptic environment including being gown qualified. Qualifications • High School degree required and Bachelor's Degree (BA or BS) preferred. • 0-3 years of relevant Metrology experience required. • Previous experience in the pharmaceutical industry preferred. PI114941917

Overview The Matron is responsible for keeping the building in a clean and orderly condition, in accordance with all SOPs and cGMP requirements. This is a 3rd shift position. Responsibilities Must be physically able to perform assigned tasks. Must have, and maintain, a good attendance record. Follow company waste disposal procedures and complies with cGMPs. Empties trash, garbage and recycling containers as assigned. Sweeps, mops and cleans assigned locker rooms, office areas and restrooms. Cleans cafeteria tables and floors as needed. Be responsible for cleanliness of assigned areas. Replenishes supplies as necessary. Read, comprehend, and follow Standard Operating Procedures (SOPs) Must be able to function and operate machine with a minimum amount of supervision after proper training period. Be responsible for the quality and quantity of work produced. Participate in team efforts to improve our work environment, product quality, efficiencies, and other initiatives identified as being beneficial to our business. Qualifications High School diploma required. Entry level - no experience required. Prefer at least 2 years of relevant experience in the pharmaceutical industry, or equivalent combination of advanced education and experience. PI114941919

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. PI114941921

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. 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 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. PI114941923

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.

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.

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. PI114941891

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. PI114941893

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. PI114941895

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 PI114941897

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 . PI114941901

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 PI114941903