- Astellas Pharma (Sanford, NC)
- …approve Certificates of Analysis (CoA) and Certificates of Testing (CoT) to support batch disposition. + Review and approve Product Specification documents to ... protocols, and reports for Quality and GMP-related functions. + Author, review , and approve Quality System records , including Nonconformances, Corrective… more
- Fujifilm (Santa Ana, CA)
- …of actions and review , obtain corrections, and completed actions to release batch records post production. **_THIS ROLE WILL WORK 3rd SHIFT 9pm-5am_** ... production meetings and address production issues and report accordingly Review batch production records and...A minimum of two (2) years of Quality Assurance ( record review or incoming inspection) in medical… more
- Kemin Industries (Lenexa, KS)
- …Independently determine the disposition of finished products, raw materials and packaging. + Review batch records and laboratory analysis results for ... regulatory teams to keep everything running smoothly. You'll handle batch records , material release, and customer investigations,...accuracy and completeness. + Independently create and review certificates of analysis. + Perform lot tracing. +… more
- Actalent (Vandalia, OH)
- … review to ensure compliance with FDA and other necessary regulations. Responsibilities + Review batch production and manufacturing records as part of lot ... release activities. + Coordinate and track CAPA, NCR, and Deviation records , ensuring timely completion. + Manage the site environmental monitoring (EM) testing… more
- Nestle (Holbrook, NY)
- …and AQL inspections + Submit samples for analytical and microbiological testing + Review batch documentation and production logbooks for accuracy + Approve ... pre-startup activities and equipment checks + Release batch records and work orders + Conduct...GMP, SOP, and documentation guidance + Participate in shift review meetings + Follow safety rules, Good Manufacturing Practices… more
- Danaher Corporation (Richmond, IL)
- …complete batch record documentation and GMP documentation, as well as review batch records completed by other team members. The essential ... requirements of the job include: + High school or equivalent; will consider experience in lieu of education + Willingness to safely handle hazardous materials + Able to wear a respirator Physical/Environment Requirements: + Ability to lift up to 45 lbs.,… more
- Cretex (Bloomington, MN)
- …assist in providing quality system training as appropriate. + Assures in process inspection, batch record review , sterile and product release complies with ... Scorecards / Key Performance Indicators for the quality of products. Review and monitor trends, communicating issues to department management. Contribute to… more
- Catalent Pharma Solutions (Greenville, NC)
- …preferably with 3 years in a Quality role. + At least 1 year of batch record review and on the floor quality assurance manufacturing support. + Position ... QA Management, supporting and providing guidance to laboratory staff as assigned. + Review Quality documentation including but not limited to review of… more
- Bausch + Lomb (Clearwater, FL)
- …processes meet product and regulatory requirements. + Oversee Sterilization Process including batch records review and validations (new validation or ... alignment with corporate quality, safety, and regulatory requirements. + Review trend analysis of EM, water testing, product testing...are met prior to release product to distribution. + Review and approve risk assessments related to new methods,… more
- ADM (Kennesaw, GA)
- …are not limited to: Batch record & release readiness + Review and approve batch production records (BPRs), attachments, and label reconciliations; ... The role delivers right-first-time coaching and GMP walkthroughs, reviews and approves batch production records for product disposition, and initiates or… more