- Merck & Co. (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...Management. Experience with Kneat, Veeva Vault, MEDS, SAP, Electronic Batch Records (MES), Trackwise and GLIMS. RCA… more
- Merck & Co. (Durham, NC)
- …of facility. Author, review , and/or edit operations and technical documentation ( Batch Records , SOPs, Job Aides, training, and engineering documents) to ... (GMP), Laboratory Techniques, Life Science, Manufacturing Quality Control, Master Batch Records , Material Selection, Microbiological Cultures, Operations… more
- Merck & Co. (Durham, NC)
- …cGMP Guidelines, Collaborative Communications, Corrective Action Management, Electronic Batch Records , GMP Compliance, Healthcare Innovation, Laboratory ... analysis, and determine product dispositionPreparing and/or providing guidance and review for regulatory filings, process descriptions, investigations, and change… more
- Endo International (Raleigh, NC)
- …reviews, and updates documentation for managing the process, including operating reports, batch records , P&IDs, etc. Reviews operating reports and batch ... operations + Must be able to climb stairs and ladders for equipment installation review , monitoring and troubleshooting. + Must be willing and able to wear PPE… more
- ITG Brands (Greensboro, NC)
- …and business teams to gather requirements and deliver integration solutions + Review development work performed by other MII developer resources to ensure ... application remediations + Experience with MES, historian, production orders, batch management + Experience delivering solutions within global organizations and… 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
- 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
