- Catalent (Philadelphia, PA)
- …individual acts as the primary liaison to our customer's quality assurance groups for batch record review and release. The Quality Assurance Document Control ... Document Control individual is responsible in preparing customer files, review and approve batch records ,...is preferred.Prior GMP experience strongly preferred.Experience with inspections or Batch Record Review a plus.Good… more
- Merck & Co. (Durham, NC)
- … and approval of batch record documentation (electronic batch record comment resolution, autoclave records , review and approval of electronic and ... during processing, review and approval of incursions, review and approval of batch record...paper batch records as applicable)Provide Quality oversight to alarm events (non-viable… more
- Catalent (San Diego, CA)
- …cGMP (Good Manufacturing Practices) regulations.Liaison between Manufacturing and QA for executed Batch Record Review and flow of documents.Liaison between ... and effectively communicates with clients in regards to Executed Batch Records (EBR) and review ...Why you should join Catalent: Awesome employee activities: Movie Day , Monthly Birthday Celebrations, Friday Bagel Breakfast, On-site Fitness… more
- Novo Nordisk Inc. (Durham, NC)
- …corporate & local SOPs Reviews & approves documentation for Quality approval - batch records & other documentation Supports & reviews investigations & root-cause ... and help us make what matters. The Position Ensures Batch Production Records (BPRs) & relevant quality...the pharmaceutical or medical device industry General knowledge of Batch Review Processes (BRP), validation processes and… more
- Merck & Co. (Durham, NC)
- …and reports issues with product accountability and SAP system discrepancies. Executes real-time batch record review and is responsible for alarm monitoring ... review , and/or edit operations and technical documentation ( Batch Records , SOPs, Job Aids, training, and...roles as needed. The position will initially be Mon-Fri, day shift. Shift schedule will change to second shift… more
- Merck & Co. (Rahway, NJ)
- …role include but are not limited to: Lead, prepare for and/or support batch processing readiness and execution activities. Prepare, review , and/or approve GMP ... GMP requirements as well as ensuring facility readiness for batch processing. In addition, this position is expected to...on best practices. Author lessons learnt through after action review summaries or other reports to capture knowledge gained.… more
- Merck & Co. (Millsboro, DE)
- …and Skills:Knowledge of site and productsContinuous Improvement, Lean, 5S experienceExperience with record review and batch releaseNOTICE FOR INTERNAL ... with Guidance from the QC Manager, ensures product/process quality through the review of GMP documentation and performs activities to ensure the efficient testing… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …includes creation of master label text, translations, and label proofs.Manages the packaging Batch Record review and approval process with Quality Assurance ... activities at the vendor, including generation of drug orders, review of shipping documentation and obtaining approval to shipAssists...preferred TravelAbility to travel up to 10% Overnight / single- day travel will be required to go to outsourcing… more
- Catalent (Manassas, VA)
- …materials necessary to meet production goals and requirements. Verifies and keeps records on incoming and outgoing product & material movements, accurately. Process ... soft chews for nutritional supplements and nutraceuticals, as well as small batch lozenges. With extensive development and manufacturing expertise and a wide range… more
- Aequor (Thousand Oaks, CA)
- …and use of quality systems. Duties include purposeful presence on the floor, electronic batch record review , SOP revision & approval, work order approval, ... ONSITE AT USTO COPY OF AMAGJP00012365 do not resub previously submitted candidates DAY & SWING SHIFT This position supports 's Quality Assurance program under the… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …preferred. Experience authoring and executing documentation including but not limited to: Batch Records , SOPs, Work Instructions, CQV protocols. Experience with ... Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, New Jersey, we are… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …is preferred. Experience reviewing/auditing documentation including but not limited to: Batch Records , SOPs, Work Instructions, Validation protocols. Proficient ... Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, New Jersey, we are… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …standards, industry standards, and global regulations. Provide Quality Oversight for batch records , change controls, SOPs, non-conformances, risk assessments, ... Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, New Jersey, we are… more
- Abbott (Columbus, OH)
- …the world. What you will do as a Batch Records Coordinator: Quality Records Auditor The Batch Record Auditor is responsible for auditing and assuring ... in Columbus, OH currently has an opportunity for a Batch Records Coordinator. This site is Abbott's...data collection. ie: PQA lab, Engineering and DQA Expedites batch review when asked by Division to… more
- Kelly Services (West Chester, OH)
- …Assisting in the correction of deficiencies found within the documentation. * Overseeing batch records review and ensuring completeness of associated ... and compliant manner, ensuring proper and complete documentation. What's a typical day as a Batch Record Coordinator? You'll be: * Communicating accurate and… more
- Regeneron Pharmaceuticals (Rensselaer, NY)
- …Providing consultation or advice in alignment with QA policies + Reviewing completed records and batch sheets and working with other departments and communicate ... + Monday-Friday, 2nd Shift In this role, a typical day might include the following: + Representing Quality Assurance...guidance on QA procedures and polices as well as review of documents for both internal and external transfers… more
- Lilly (Durham, NC)
- …product released to the market meets applicable GMP standards. **Responsibilities:** + Review related batch records associated with parenteral manufacture, ... be a member of the Quality Assurance disposition team. The Quality Assurance Batch Disposition team assures patients worldwide of safe and efficacious drug and… more
- City and County of San Francisco (San Francisco, CA)
- Hybrid Workplace: Our workplace has a hybrid/flexible weekly schedule, where colleagues work 1 day onsite (in the San Francisco office) and 4 days from home, subject ... to periodic review and approval. Controller's Office The Controller is the...2017. This is now the central system of financial record and budgetary control for the City and County… more
- Regeneron Pharmaceuticals (Troy, NY)
- We are currently looking to fill a Quality Assurance Specialist ( Batch Disposition) position. This position performs activities supporting dispositioning product ... cGMPs, SOPs, and Regeneron Standard Requirement Documents. In this role, a typical day might include the following: + Representing Quality Assurance in support of… more
- Kelly Services (Raynham, MA)
- Kelly FSP Science and Clinical is currently seeking a Records Review Associate 2nd Shift for a long-term engagement with one of our Global Pharmaceutical ... paid time off, including holiday, vacation, and sick/personal time ** Records Review Technician 1** *2nd Shift Mon.-Fri....**Position Duties and Responsibilities:** Batch Release and Records Management Audits batch records … more
