- Novo Nordisk (Clayton, NC)
- …& local SOPs + Review & approve, in a timely manner, executed batch production records (BPRs) ensuring accurateness & compliance with approved procedures & ... Follow-up on and trouble-shoot challenges/ clarifications needed to ensure high-quality batch review . Participate in the continuous improvement of the… more
- Fujifilm (Holly Springs, NC)
- …role, you will oversee our Quality Product and Validation teams, along with the batch review and release teams. Your responsibilities will include ensuring that ... and manages the QA DSM Operations teams, including the Batch Review and Release teams and the...other GMP functions (manufacturing, MSAT, Engineering) * Strong track record of driving operational excellence * Experience with the… more
- Otsuka America Pharmaceutical Inc. (Raleigh, NC)
- …+ 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
- Fujifilm (Holly Springs, NC)
- …Actions Preventative Actions within Trackwise * Leads continuous improvement initiatives * Manages batch record review and cycle time Key Performance ... batch records in electronicsystems managing the production scheduler, batch record reviewers, manufacturing execution systems associates, and training… more
- Merck (Durham, NC)
- …compliance with cGMP, regulations, and our Company's Quality Management System focusing on batch record review , process/aseptic observations, critical site ... Leads and Supports the Aseptic Observer Program (AOP) and Batch Record Review (BRR) workstreams...+ Experience with Kneat, Veeva Vault, MEDS, SAP, Electronic Batch Records (MES), Trackwise and GLIMS. +… more
- ThermoFisher Scientific (Greenville, NC)
- …and continuously improving manufacturing operations. This role oversees Deviation Management, Batch Record Review , Process Improvement, and Operations ... stream. + Lead and develop the Operations Support organization, including Deviation Management, Batch Record Review , Process Improvement, and Learning &… more
- BD (Becton, Dickinson and Company) (Mebane, NC)
- …internal/external audits related to training. + ** Batch Record Review :** Performtimelyandaccuratereview of batch records to ensure compliance with ... Support updates to manufacturing documentation including SOPs, work instructions, and batch records . + **Standard Work Documentation:** Assistin the creation… more
- Sumitomo Pharma (Morrisville, NC)
- …product manufacturing and aseptic techniques. + Relevant experience and knowledge of manufacturing, batch record review , and/or analytical analyses for the ... + Responsible for providing QA review /approval of the completed Manufacturing batch records in a timely manner and ensuring that the entries adhere to the… more
- ThermoFisher Scientific (Greenville, NC)
- …Analysis to support deviation investigations of moderate to high complexity + Performs quality batch record review + Aids in identification of continuous ... operations including manufacturing, filling, packaging and inspection, and associated non batch specific activities in for both commercial and product development… more
- United Therapeutics (Research Triangle Park, NC)
- …facility, this is the role for you. + Weigh raw materials per Production Batch Record specifications to ensure products are properly formulated + Operate, clean, ... the execution of batches in the production process + Review batch manufacturing documentation as well as...batch manufacturing documentation as well as all cleaning records and labels to ensure accuracy and adherence to… more