- Catalent Pharma Solutions (Morrisville, NC)
- …and equipment + Fill product in aseptic processing area in compliance with SOPs, batch record , and cGMPs + All other duties as assigned **The Candidate:** ... every patient, consumer, and Catalent employee.** **The Role:** + Review experimental product trial paperwork to ensure use of...Prepare and assist in the preparation of all production batch requirements + Perform all steps and processes necessary… more
- Lilly (Indianapolis, IN)
- …are in place and are being executed, including appropriate evaluation of batch production records . + Ensuring appropriate oversight of Contract Manufacturers ... and monitoring contract manufacturers, GMP service providers, and consultants. + Ensuring record retention processes are robust for the Small Molecule Plant. **Key… more
- Gilead Sciences, Inc. (Santa Monica, CA)
- …and external) including but not limited to: master and executed production batch records , investigations, corrective actions, change controls, protocols and ... product disposition packages. Project management of disposition deliverables (eg investigations, batch records ) ensuring timely critical material and/or product… more
- Colgate-Palmolive (Cambridge, OH)
- …Microsoft or Google Suite. + Proven documentation skills and management of batch records / production paperwork. **Physical Requirements** + This position will ... Colgate Research and Technology Center. + Assist in compilation of Antibacterial Batch Release Records , reviewing for documentation accuracy, and providing… more
- PCI Pharma Services (Rockford, IL)
- …with management. + Review and approve documentation including specifications and batch records , as required. + Create bill of materials, component item ... but is not limited to, the following: Lot/Expiration form creation, material receipt/release, batch record preparation and ERP work order creation. + Track… more
- Actalent (Maple Grove, MN)
- … Review and approve product-related documents including specifications, master batch records , change control documents, CAPA, investigations, deviations, ... change management, risk management, and issue resolution. Responsibilities + Perform executed batch record reviews and product disposition of finished products… more
- Bristol Myers Squibb (Indianapolis, IN)
- …including review and approval of Deviations, CAPAs, Change Controls, documents, Batch Records , and Material and Lot Disposition. This person may also ... quality oversight on manufacturing and validation activities. + Perform real time review of manufacturing records . + Perform periodic walkthroughs of… more
- Lilly (Pleasant Prairie, WI)
- …+ Establish and ensure a system is in place for evaluating and releasing batch records in accordance with regulations and company standards. + Ensure all ... place for approving specifications, sampling instructions, test methods & batch records . + Ensure that all required...control is in place (Quality Lead Team, established Deviation Review Board, Change Control Board, CAPA board) to ensure… more
- Lilly (Indianapolis, IN)
- …with CMs. Provide on-site support during inspections. + Participate on the Technical Review Board + Evaluate and disposition API batches, if required. + Ensure that ... Certificates of Environmental Monitoring (where applicable), and deviations, changes and batch documentation that demonstrates requirements have been met prior to … more
- Merck (Durham, NC)
- …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