- BeiGene (Hopewell, NJ)
- …based in Hopewell, NJ. Manages the operational performance of the Material and Product Release QA function, ensuring the successful day to day management ... SAP + Reviews and approves product and material specifications. + Represents Quality Assurance...+ Ensuring the development of Material and Product Release QA SOPs (writing,… more
- Fujifilm (Trenton, NJ)
- …with the various Business Units , QA /RA, and HCUS/MIPD stakeholders to develop Product Release schedules and a five (5) year product roadmap. Propose ... release to the regional BU(s) and Regional Product Marketing team(s). + Coordinate with QA /RA...+ As needed, develop and produce presentation and marketing materials . + Ensure that HCUS policies and procedures are… more
- University of Pennsylvania (Philadelphia, PA)
- …external audits, DFPs, CAPAs review. + Assisting Manager as needed to help with raw materials release , new hire QA Associate train. Position contingent upon ... and wellness programs and resources, and much more. Posted Job Title Quality Assurance Specialist (Regulatory) CVPF(Center for Cellular Immunotherapy) Job… more
- BeiGene (Hopewell, NJ)
- …QA Team. **_Essential Functions of the job_** **_:_** + Developing and implementing the Quality Assurance Batch Release strategy, to ensure it meets the ... with resources as needed. + Implementing and monitoring all Quality Assurance shop floor and batch systems...out the review and approval of batch documentation and product release for commercial & clinical products… more
- Sumitomo Pharma (Trenton, NJ)
- …methods for release and stability testing of drug substance, drug product and other materials , to domestic and international contract manufacturing ... recommendations for manufacturing controls, sampling and testing to ensure product quality and compliance with GMPs from...regulatory filings and therefore must have experience in a Quality Assurance and/or Quality Control… more
- Kelly Services (Fort Washington, PA)
- …Depending on experience The QA Specialist is responsible for providing daily Quality Assurance support to the manufacturing site to ensure internal and ... include but are not limited to Batch Record Review, Product Release , Standard Operating Procedures, Investigations, CAPA,...Maintenance and other departments as it relates to site Quality Assurance responsibilities.. As a QA… more
- Berry Global (Monroe, NJ)
- …throughout the Berry organization. **5.0 Organizational Relationship:** 5.1 Reports to the Quality Assurance Manager. We are an Equal Opportunity Employer and ... Inspect line clearance as assigned by Lead Inspector 3.6 Release all product manufactured in the assigned...4.2.9 Required to read labels on cartons, Bill of Materials , pack patterns, and other QA related… more
- Lilly (Philadelphia, PA)
- …external agency inspection that impact Lilly products. + Follow up on Global Quality Assurance Auditing & Compliance (GQAAC) audit findings, ensuring that the ... in Plant may be also responsible for final disposition of manufactured and/or packaged drug product batches. This role serves as DPEM QA primary contact to the… more
- Merck (West Point, PA)
- **Job Description** Our Quality Assurance group ensures every single material inside our products is manufactured, processed, tested, packaged, stored and ... IPT Quality Lead, ensures product /process quality , performs activities to facilitate the release ...position; prior batch record experience is a plus + Quality assurance audits or inspection of vaccine… more
- Kedrion Biopharma (Hillsborough, NJ)
- …make sure that all product and/or incoming materials meet quality expectations, according to material specifications. Quality Warehouse Associate is ... raw materials and components + Inspection and release of final product labels by verifying... or Operations department plus. + Experience with biologics Quality Assurance or Operations plus. + Plasma… more
- Integra LifeSciences (Plainsboro, NJ)
- …Track Non-Conformances, monitor impact on product availability and work closely with Quality Assurance ( QA ) to prioritize NCs. + Coordinate with ... overseeing and coordinating all scheduling activities for the manufacturing, testing, release , and shipping of new product introductions (NPIs), sub-assemblies,… more
- Endo International (Horsham, PA)
- …junior QA team members. Batch Record/Reports Review + Supports the QA batch release functions for cGMP commercial, clinical, and development manufacturing ... of annual product review and updates for regulatory filing(s), batch release metrics, and department reporting as applicable. + Releases consumables and raw … more
- Teledyne (Montgomeryville, PA)
- …**Job Summary:** Develop, support, and maintain documentation and configuration control. Support the quality assurance group and its ISO 9001/AS9100 Quality ... Participate in the review of proposed changes for risk and impact to product quality , reliability and possible requalification requirements * Actively support… more