- Curia (Albuquerque, NM)
- …primary quality assurance contact for CURIA-Albuquerque clients + Responsible for ensuring batch records have been thoroughly reviewed before product disposition ... improvement initiatives + Will provide quality training related to batch review , sitewide + Read/interpret SOPs to...pressure to meet customer and business deadlines associated with batch record lot release Other Qualifications +… more
- Catalent Pharma Solutions (San Diego, CA)
- …cGMP (Good Manufacturing Practices) regulations + Liaison between Manufacturing and QA for executed Batch Record Review and flow of documents + Liaison ... between QA and client and effectively communicates with clients in regards to Executed Batch Records (EBR) and review status + Tracks status of Executed … more
- Catalent Pharma Solutions (Kansas City, MO)
- …diploma or equivalent required + Bachelor's degree is preferred + Prior experience in manufacturing batch record review highly preferred + Minimum of 3 years ... packaging material and component requests + Preparation of packaging batch record documentation in compliance with SOPs...documentation in compliance with SOPs and cGMP + Accurately review packaging batch records prior… 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
- PCI Pharma Services (Madison, WI)
- …program. The individual serving in this role will also provide support on batch record review , deviation investigations, CAPAs, and other manufacturing ... support teams + Ensure manufacturing instruction set and production records reflect practice, are aligned to cGMPs/ISO and corporate...to cGMPs/ISO and corporate standards + Provide support of batch record review , deviations, and… more
- Otsuka America Pharmaceutical Inc. (Boise, ID)
- …+ 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
- RPM International, Inc. (Ellaville, GA)
- …and expediently addressing gaps in data and/or documentation when they arise during post- batch review process. + Review of manufacturing data/settings for ... Job Description ESSENTIAL FUNCTIONS: + Perform post- batch activities in a timely manner, efficiently, and...and/or databases. + Scan and index manufacturing packets and records into company document database. + End production orders… more
- Bristol Myers Squibb (Devens, MA)
- …a local process owner for core QASF systems/processes including but not limited to Alarm Review , Batch Record Review , and the GMP Walkthrough Program. ... incumbent shall flex to support ad-hoc deviation approval or batch record review as requested...systems such as Manufacturing Execution Systems (MES) for electronic batch records ; Enterprise Resource Planning (ERP) such… more
- Actalent (Maryland Heights, MO)
- …perform other general duties as required by supervision. Essential Skills + Proficiency in batch record review and sampling. + 3-5 years of quality/quality ... and efficient review and disposition of completed batch record documentation, ensuring adherence to Good...on the floor and 50% at a desk reviewing batch records . Job Type & Location This… more