- Mallinckrodt Pharmaceuticals (St. Louis, MO)
- …issue resolution. This role is also responsible for return good inspections, cGMP area inspections and product inspections. This role ensures QA compliance and ... that cGMP principles are adhered to. Job Description ESSENTIAL FUNCTIONS...of returned goods + Follow all internal and basic cGMP guidelines for pharmaceutical operations + Perform GMP walkthroughs… more
- Cambrex High Point (Charles City, IA)
- …raw materials, intermediates, and finished products. The role requires adherence to EPA, FDA, cGMP , cGLP, and DEA regulations, as well as company SOPs. The Chemist I ... as needed. Responsibilities + Adhere to all EPA, FDA, cGMP , cGLP DEA regulations and internal SOP's as they...are required to adhere to DEA, EPA, FDA and cGMP regulations as they relate to the operation of… more
- Fujifilm (Holly Springs, NC)
- …Drug Product Manufacturing including training of new colleagues. Maintains compliance of cGMP documents and to assist in qualification of equipment and all aspects ... (pH, conductivity, visual inspection) * Executes validation protocols according to cGMP Standard Operating Procedures (SOPs) * Maintains training to perform all… more
- Actalent (Grand Rapids, MI)
- …As an Aseptic Technician, you will execute tasks in compliance with CGMP guidelines and Standard Operating Procedures to manufacture, inspect, and package products. ... Technician qualification blocks while documenting procedural steps according to CGMP standards, clean room behavior, and Standard Operating Procedures.… more
- Bristol Myers Squibb (Summit, NJ)
- …with Bristol-Myers Squibb policies, standards, procedures, and Global cGMP . Functional responsibilities include ensuring manufacturing compliance with applicable ... manufacturing. + Must have sound knowledge and experience in FDA-regulated cGMP manufacturing operations and processes. + Must be action-oriented and… more
- Actalent (Shawnee, KS)
- …are seeking a detail-oriented CMMS Administrator to support a critical cGMP document transfer project. This role involves reviewing SAP-based maintenance documents ... new FIX system. The ideal candidate will have a strong understanding of cGMP (Current Good Manufacturing Practices) and experience with Excel, Word, and Adobe.… more
- Curia (Albuquerque, NM)
- …equipment, processes, utilities, systems, and components in alignment with cGMP regulations, internal procedures, and applicable regulatory expectations. This ... protocols for equipment, utilities, systems, and processes in accordance with cGMP , internal procedures, and regulatory requirements. + Author and execute test… more
- University of Colorado (Aurora, CO)
- …to manufacturing. + Scale-up of multiple biologics manufacturing processes for the cGMP suites. + Capital, facility, and equipment upgrades and projects. + Identify ... and purification process development. + At least one year of cGMP manufacturing experience. + Experience in planning biologics-based manufacturing operations. +… more
- The US Pharmacopeial Convention (USP) (Rockville, MD)
- …and implementing activities related to current Good Manufacturing Practice ( cGMP ) site audits, quality control and manufacturing (QCM) product documentation ... You will be responsible for the preparation and/or evaluation of cGMP site audits/reports, QCM documentation/reports, and test data/results regarding facilities and… more
- Sanofi Group (Swiftwater, PA)
- …- eye testing a prerequisite) of all products within functional areas. + Perform cGMP audits within functional areas by conducting a thorough review of processes and ... documentation. Identify and communicate cGMP compliance deficiencies to upper management, recommend appropriate corrective...included in the Change Control, so proper assessments of cGMP areas can be evaluated, and risk mitigated. +… more
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