- Bristol Myers Squibb (Summit, NJ)
- … batch review , or disposition is preferred. + Working knowledge of Electronic Batch Records (EBR), Review by Exception (RBE), and MES Recipe object ... (eg, EBR) updates and technical insight. + Develop inputs into electronic batch record /process automation technologies to advance digital manufacturing strategy.… more
- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- …+ Establishes and maintain the effectiveness of Quality Systems for managing the batch record review and release process Quality Management Activities ... associated with the systems noted above. + Improves supplier quality performance for batch record review and release process for OAPI GMP release of Contract… more
- Bristol Myers Squibb (Summit, NJ)
- …and WCT members. * Performs batch record reviews (BRR) or Electronic Batch Record review by exception. * Ensures that all documentation produced by ... review , author, or approve SOP, WI, master batch records . Safety: * Takes personal responsibility...the deviation and ensures timely entry of the deviation record information in the system. * Maintains deviation metrics… more
- Bristol Myers Squibb (Summit, NJ)
- …their WCT members. + Performs batch record reviews (BRR) or Electronic Batch Record review by exception. + Ensures that all documentation produced by ... from GMP tasks if observed to not comply with SOPs, Work Instructions, or batch records , including safety trainings. Team Building and Development: + Is… more
- Actalent (Parsippany Troy Hills, NJ)
- …needed. Provides guidance and technical knowledge for junior staff as required. Skills batch record review , Quality assurance, standard operating procedure, ... glp, gmp environment Top Skills Details batch record review ,Quality assurance,standard operating procedure,glp,gmp environment Additional Skills &… more
- Bristol Myers Squibb (Summit, NJ)
- …by the team. Execute/perform batch record reviews (BRR) or Electronic Batch Record review by exception and ensure that all documentation produced ... profiles for all new hired staff and administering the performance review process, differentiating performance, giving recognition when deserved and continuous… more
- Bristol Myers Squibb (Summit, NJ)
- …the team . Execute/p erform batch record reviews (BRR) or Electronic Batch Record review by exception and ensure that all documentation produced by ... profiles for all new hired staff and administering the performance review process, differentiating performance, giving recognition when deserved and continuous… more
- Astrix Technology (New Brunswick, NJ)
- …techniques + Follow GMP guidelines and environmental health and safety policies + Review executed batch records and associated documentation for accuracy ... technologies (eg, bioreactor bags, manifolds, tube sets) + Skilled in reviewing batch records , supporting documentation, and compliance practices + Knowledge of… more
- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- …quality oversight of assigned GMP contract manufacturers. + Responsible for the OPDC GPQ batch record review and release activities of assigned products ... and change controls per Otsuka Policies and Procedures. Dispositions quality system records to ensure their timely initiation, execution, and closure. + Provides… more
- Actalent (Wharton, NJ)
- …Strong ability to interpret and follow SOPs, Work Instructions, Master Batch Records , and product specifications. Excellent documentation accuracy, attention ... Review documentation to assure accuracy prior to submittal to QA Release team. Review Master Batch Sheets. Act as Lead QA Inspector in his or her absence to… more