16 jobs found in lakewood township

Renaissance LLC All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status. 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. This position is a 2nd shift position and exempt from...

Renaissance LLC All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status. 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. This position is a 2nd shift position and exempt from...

Renaissance LLC All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status. Overview The Operational Excellence Quality Engineer II will be responsible for driving business transformation in the laboratory areas through the implementation of Operational Excellence tools and culture. Responsibilities • Define, implement, and refine continuous improvement initiatives as an internal coach and change agent with specific focus on our laboratories (analytical, microbiology, spray) • Operate with a sense of urgency to provide tangible improvements in needed areas through lean laboratories and six sigma best practices • Communicate effectively with numerous stakeholders to foster a sense of collaborative improvement • Educate stakeholders at front line and...

Renaissance LLC All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status. Overview The Operational Excellence Quality Engineer II will be responsible for driving business transformation in the laboratory areas through the implementation of Operational Excellence tools and culture. Responsibilities • Define, implement, and refine continuous improvement initiatives as an internal coach and change agent with specific focus on our laboratories (analytical, microbiology, spray) • Operate with a sense of urgency to provide tangible improvements in needed areas through lean laboratories and six sigma best practices • Communicate effectively with numerous stakeholders to foster a sense of collaborative improvement • Educate stakeholders at front line and...

Renaissance LLC All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status. Overview The Facilities MEP Engineer will ensure the continued efficient operation of the Lakewood site by providing service and support to the utility systems, existing equipment and all Facility related projects. This position is exempt from overtime. Responsibilities • Responsible for understanding and continuous improvement of existing plant utilities and management of equipment life expectancies. • Troubleshooting and resolving facility issues related to Grade A-D clean room design including temperature, relative humidity, differential pressure, or particulate recovery issues • Will oversee execution and management of Facility related projects such as...

Renaissance LLC All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status. Overview The Administrative Assistant provides secretarial and varied administrative support to an assigned department for a period of three months. This is a temporary role. Responsibilities Perform several tasks simultaneously. Must be able to organize and prioritize work in order to accomplish tasks assigned. Interact with other department personnel at all levels, and with clients, in order to provide or obtain information. Maintains data within a variety of databases for the assigned department, and uses the data to generate reports. Processes various forms, distributes department mail and arranges special shipments through a mail courier service, if needed....

Renaissance LLC All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status. Overview The Administrative Assistant provides secretarial and varied administrative support to an assigned department for a period of three months. This is a temporary role. Responsibilities Perform several tasks simultaneously. Must be able to organize and prioritize work in order to accomplish tasks assigned. Interact with other department personnel at all levels, and with clients, in order to provide or obtain information. Maintains data within a variety of databases for the assigned department, and uses the data to generate reports. Processes various forms, distributes department mail and arranges special shipments through a mail courier service, if needed....

Renaissance LLC All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status. Overview The Process Mechanic performs activities including, but are not limited to, mechanical, electrical, pneumatic, and troubleshooting and repair of packaging and production machines while following FDA regulations, cGMPs, OSHA requirements, company practices and company policies. The Process Mechanic will assess and consider on a daily basis the safety of our employees, the security of our assets and the quality of the services they deliver. This position will also coordinate outside contractors and vendors for various services. The Process Mechanic may also be required to perform facilities maintenance. This is a third shift position and hours are 11:00 pm until 7:30 am....

Renaissance LLC All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status. Overview The Materials Coordinator I will assist in the efficient receipt, storage, movement and inventory of items throughout the Warehouse. This is a third shift position and the hours are approximately 11:00 pm - 7:30 am 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. •...

Renaissance LLC All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status. Overview The Technical Reviewer performs review of documentation related to microbiological testing of product, water and environmental samples under minimal supervision. Assists lab management and technical reviewers as directed. Responsibilities Review and release all environmental monitoring data for the site to ensure accuracy and completeness Interact with Operations staff to facilitate data and documentation corrections Review laboratory data for growth promotion, bioburden, biological indicators, water testing, etc. Release manufacturing areas after recovery using the ASCN in Trackwise Writes Trackwise notifications and deviations and completes CAPA's Creates and...

Renaissance LLC All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status. Overview The Spray Auditor will provide technical support for routine data integration and reviewing activities of raw materials, finished product, bulk in-process and component documentation. Identify basic technical problems, a typical test results or methodology and assist in the investigation to correct them. Remediate complicated technical issues related to the collection of data. Other important duties include ensuring notebooks and reports are in compliance with regulatory guidelines, completing projects' data review within time limits, and verifying mathematical calculations, interpreting results, recording observations and responding to and assisting in audits and...

Renaissance LLC All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status. Overview The Microbiology Project Coordinator directly supports in the daily management of multiple projects for our healthcare partners. Specific responsibilities include the creation and maintenance of laboratory timelines and documentation review such as protocols and applicable change controls for the projects. As the laboratory point of contact with the Project Managers and Project Coordinators the individual needs to maintain strong professional relationships with them through setting realistic expectations and timely communications. Responsibilities • Participate in internal, cross-functional teams to ensure project milestones are met as contracted with our healthcare...

Renaissance LLC All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status. Overview The Project Engineer is responsible for managing construction and engineering projects in a cGMP environment through planning, organizing and controlling all elements of the project. Have the ability and competency to oversee all facility and utility upgrade projects. Apply engineering principles to support operational initiatives such as equipment reliability enhancement, environmental sustainability, project execution standardization and continuous improvement. Ability to work in a fast-pace environment and the competence to concurrently handle multiple projects and operational initiatives. Responsibilities • Manage small, medium to large projects from requirement...

Renaissance LLC All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status. Overview The IT Compliance and Validation Supervisor is position is responsible for leading a team that is tasked with supporting the design, installation, implementation and validation of electronic systems to meet all applicable industry standards and regulatory requirements. The successful candidate will act as an advisor to the Director of IT in all areas of system compliance and validation and must have the ability to raise issues that they see as risk to the company. This position frequently interacts with customers and other groups at the Site and coordinates the IT validation tasks. Responsibilities • Guides the work efforts of direct reports, and mentors them in all...

Renaissance LLC All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status. Overview The Process Mechanic- Electromechanical will perform activities including, but are not limited to mechanical, electrical, pneumatic, and troubleshooting and repair of packaging and production machines while following FDA regulations, cGMPs, OSHA requirements, company practices and company policies. This position may also include light facilities maintenance. This is a 3rd shift position. Responsibilities • Perform Line change over, set-up, start-up, including vision system training and data collection • Identify parts needed for repairs using parts manual for specific equipment and will assemble requisition for supervisor to order parts. • Responsible for on-going...

Renaissance LLC All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status. Overview The Compounder's primary responsibility is for the execution of bulk product batch processing, inclusive of all process related and administrative activities, as well as Equipment Preparation activities as declared in Compounder 1. Responsibilities Follow manufacturing procedures to process bulk product. Batches to be made right the first time. Follow manufacturing procedures specific to the task being performed. Perform compounding functions as deemed necessary by operations management and functions where qualified to perform. Operation of processing equipment, and the execution of manual and automated cleaning, sanitizing, and sterilization of tanks and...