- Regeneron Pharmaceuticals (Rensselaer, NY)
- We are currently looking to fill a Supervisor Quality Assurance ( Batch Record Review ) position. This position performs activities supporting dispositioning ... associated with disposition of raw materials and product (eg receipt, inspection, document review , shipping, etc.), activities may be on the floor or at a desk… more
- Kelly Services (Lodi, CA)
- … records and documents, for completeness and compliance with QSR and ISO requirements. + Review batch record to support release of raw materials, work in ... **Overview:** The Quality Assurance Specialist is responsible for reviewing records to comply with QSR and ISO requirements. They...signing in relevant sections of documents. + Reviewing the batch records online, if necessary. + … more
- Catalent Pharma Solutions (Hanover, MD)
- …testing, packaging, and release of cell and gene therapy products + Independently executes batch record review for completeness, accuracy and cGMP compliance ... documentation practices (GDP), including but not limited to: executed batch records , master batch ...and SOPs + Compile and report performance metrics for Batch Review and Release + Contributes to… more
- Catalent Pharma Solutions (Harmans, MD)
- …support batch disposition + Review of terminated, discontinued and rejected batch records and other GMP documents as applicable. + Responsible for the ... QA Operations support on maintaining, filing and scanning of batch records and supporting documentation. This role...responsible for the timely data entry and maintenance of batch review life cycle tracker and visual… more
- Catalent Pharma Solutions (Harmans, MD)
- …packaging, and release of cell and gene therapy products. + Independently executes batch record review for completeness, accuracy and cGMP compliance. ... documentation practices (GDP), including but not limited to: executed batch records , master batch ...by QA Management. + Collaborates within Manufacturing to resolve batch record discrepancies or errors as it… 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 ... guidance on QA procedures and polices as well as review of documents for both internal and external transfers...Performing activities associated with disposition of product (eg document review , shipping), activities may be on the floor or… more
- ThermoFisher Scientific (Cincinnati, OH)
- …needs, driving the team's daily work plan to ensure results are met. Lead the batch record disposition team to achieve site goals for delivery and accuracy ... ensuring compliance with all relevant directives and procedures. Compile and review batch release documentation packages to ensure they meet our stringent… more
- Aerotek (Chicago Heights, IL)
- …and effective communication. **Responsibilities** + Attend daily safety meetings. + Receive and review batch sheets. + Formulate chemicals and weigh out raw ... cleaning while machines are running or when batches are completed. + Communicate batch records with the next shift and supervisors. + Work closely with a helper… more
- Danaher Corporation (Duncan, SC)
- …and delivery of solutions that safeguard and improve human health. What you'll do: + Review batch documentation records to ensure goods are being released in ... internal procedures in a timely and thorough manner + Review Certificates of Sterility / Irradiation to ensure that...that goods are treated according to the validated settings. Review customer facing documents to assure GMP compliance +… 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
- BeiGene (Hopewell, NJ)
- …Responsibilities:** + Supervises direct reports within the Manufacturing QA Team, assist with batch review and release, as necessary. QA, Mfg. shop floor QA ... availability of adequate competent resources to carry out the review and approval of batch documentation and...Quality Operations on the shop floor. + Demonstrable track record and skills/experience gained within a similar position(s), at… more
- Curia (Albuquerque, NM)
- …biotechnology industries. The Quality Program Management Manager will lead and manage our QA batch record review and product disposition team. The manager is ... the timely review and disposition of executed batch records (clinical, commercial, and media fills)....supply commitments. Key responsibilities include establishing, monitoring, and improving batch record review and disposition… more
- Lilly (Indianapolis, IN)
- …manner. . Lead, mentor, and coach operations and support personnel on quality matters. . Review related batch records (inclusive of third-party batch ... records such as non-conformance investigations, change controls, procedures, master batch record reviews, technical protocols/reports validations, batch … more
- Catalent Pharma Solutions (Harmans, MD)
- …as routine production tasks. + Proficient knowledge of documentation including comprehension, review & establishing Batch Production Records , SOP's, ... manufacturing and support area of manufacturing using SOP's and batch records . Operating production equipment for upstream...Ensure batches adhere to established Quality standards. + GMP batch review and close-out with Quality Assurance… more
- Catalent Pharma Solutions (Harmans, MD)
- …as routine production tasks. + Proficient knowledge of documentation including comprehension, review & establishing Batch Production Records , SOP's, ... procedures for upstream, downstream, and solution preparation manufacturing using SOP's and batch records . Operating production equipment in support of all drug… more
- PCI Pharma Services (Philadelphia, PA)
- …individual will contact the appropriate personnel to recalibrate and/or remediate the issue. Review batch record (MPI) to ensure equipment challenges and ... when the audit was conducted. Identify proactively gaps in batch records and PDRs to mitigate deviations...QA inspectors/auditors, batch record preparation, batch record review , document change… more
- Kelly Services (Barceloneta, PR)
- …required batch information into the lot restriction management system. . Assemble the batch record review package and label per the approved retention ... API and/or finished Drug Product electronic and manual (paper) batch records to assure compliance with applicable...determine the need for a corrective action. . Track/trend batch record discrepancies per procedural requirements and… more
- Nestle (Bohemia, NY)
- …years of Previous Quality Assurance experience in related field preferred + Batch Record /Documentation Review experience preferred + Technical proficiency ... Runs and maintains reports + Track and trend key indicators related to batch review as needed + Performs other duties as assigned. **Qualifications:** + High… more
- J&J Family of Companies (Athens, GA)
- …At Johnson & Johnson, we all belong. In this role you will provide Quality Assurance batch record review and release associated with the manufacture of safe, ... policies and current Good Manufacturing Practices. Key Responsibilities: + Review and assess batch records ...(SOPs) + Maintain accurate and complete documentation of all batch record review activities. +… more
- PCI Pharma Services (Bedford, NH)
- …to internal procedures and external standards. Primary responsibilities for this role includes Batch Record Review , Lot Disposition, and Quality System ... compliance with cGMPs, site SOPs, and regulatory requirements. Prioritize record review in support of business needs...status and communicate release needs throughout the organization + Review and approve master batch records… more