- 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
- Catalent Pharma Solutions (Harmans, 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 (Hanover, 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
- 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 (Alsip, 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)
- …industries. The Quality Program Management Supervisor will oversee and guide the QA batch record review and product disposition team. The supervisor ... the timely review and disposition of executed batch records (clinical, commercial, and media fills)....responsibilities include supporting the establishment, tracking, and improvement of 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
- 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
- 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
- BeiGene (San Mateo, CA)
- …ensure the product quality is compliant with regulatory requirements and BeiGene standards. + Perform batch record review + Lead batch related deviation ... implementation at CMO + Manage change controls + Perform batch dispositions + Perform PIP (Person in Plant) +...Vendor Management team on vendor performance monitoring and periodic review , support in audits as required + Will work… more
- Merck (West Point, PA)
- …area as part of a Quality IPT (Integrated Product Team). With guidance from the Batch Record Review Quality Manager, the Quality Specialist ensures quality, ... including SAP, GLIMS and electronic logbook, laboratory data, and batch record platforms + Provides presence on...for review /approval of new and updated Master Batch Records + Performs review /approval… more
- PCI Pharma Services (Philadelphia, PA)
- …in-process inspections have been performed within compliance. The Quality Auditor performs real-time batch record review during batch processing in ... process equipment are within required specifications. + Performs in-line review of batch record (MPI)...the audit was conducted. + Proactively identify gaps in batch records to mitigate deviations and documentation… more
- PCI Pharma Services (Rockford, IL)
- …decisions. + Responsible for maintaining and collecting team Quality metrics. + Present Executed Batch Record review status at the Daily Planning meeting. + ... Responsible for the daily internal Batch Record Right First Time notification. +...photographs and randomization files). + Prepares and submits executed Batch Records , accountability reports and necessary documentation… more
- PCI Pharma Services (Philadelphia, PA)
- …in-process inspections have been performed within compliance. The Quality Auditor performs real-time batch record review during batch processing in ... process equipment are within required specifications. + Performs in-line review of batch record (MPI)...within acceptable job parameters. + Proactively identify gaps in batch records to mitigate deviations and documentation… more
- Catalent Pharma Solutions (Harmans, MD)
- …for upstream manufacturing and support area of manufacturing using SOP's and batch records . Operating production equipment for upstream processing that may ... development groups to assist with tech-transfer, scale-up, and translation activities. + GMP batch review and close-out with Quality Assurance group. + Conduct… more