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Well-versed in chemical process manufacturing, plant safety rules and regulations, Process Safety Management (PSM), current Good Manufacturing Practices (cGMP), environmental compliance standards, site quality processes, and budgetary cost control.
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Develop validation documents per FDA cGMP and GAMP standards, functional specifications, design specifications and requirements trace matrices. Experience in Control Systems (Emerson DeltaV, Allen Bradley, Foxboro, Siemens, Honeywell.
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Familiarity with cGMP, Good Laboratory Practices (GLP), and project management principles. Bachelor's degree in Pharmaceutical Science, Chemical Engineering, Food Science, Chemistry, or a related scientific discipline.
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JSat Automation is hiring an Automation Validation Engineer for their Blue Bell Office. Experience with SCADA, MES, and database systems, or computer system validation are considered a plus. Design and develop manufacturing control systems in support of process operations.
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May serve as study director, principal investigator, or project leader for GLP and CGMP studies. Completes complex work for research and development, CGMP and GLP studies and documents and reports data in a timely manner according to regulatory guidelines.
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Downstream biologics process development technology transfer, scale-up and ongoing manufacturing of biologics (cGMP) including technical support for nonconformance investigations and other commercial support activities.
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This work is supported by the Cancer Center Clinical Trials Unit, a new cGMP and TCT laboratory, fully characterized tumor samples repository and new state-of-the-art Medical Center opened in 2021, all on the Medical School campus.
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Learn and maintain thorough familiarity and compliance with all state and federal regulations, Standard Operating Procedure Manual, Occupational Safety and Health Administration (OSHA), Clinical Laboratory Improvement Amendments (CLIA), Current Good Manufacturing Practice (cGMP), and internal Company Procedures.
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CORE COMPETENCIES: PACKAGING TECHNICIAN I (0-24 Month Period) Must be proficient in two Packaging Zones (Zone 4 1 other) Review and begin building knowledge of required SOP and cGMP guidelines for position.
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You'll be responsible for providing Quality Systems oversight and support for the development and operations of a commercial scale state-of-the-art cGMP cell therapy manufacturing and laboratory facilities.
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Aseptic, Sterile Injectables, cGMP, Downstream, Fill finish, Gmp, Cleanroom, Laboratory, Contract Manufacturing, Compound, Compounding, batch processing, Autoclave, pharmaceutical manufacturing, pharmaceutical, gowning, Chemistry, Sop, Batching, Aseptic technique, Quality assurance, Inspection, Sanitization, Batch record.
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Performs basic preparatory procedures on feed samples containing pharmaceutical ingredients according to FDA cGMP requirements. The Merck Animal Health lab in Lawrence, KS is looking to add a temporary worker for the rest of 2024, with a possibility to extend the contract into 2025.
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Extensive management experience in a cGMP testing laboratory environment, with knowledge of regulatory and compendial guidelines as related to cell-based assay requirements, aseptic processing, and biosafety of cell therapy products.
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Participate in training programs as needed (e.g., BRC/SQF, cGMP, HACCP, Safety) 3+ years of quality experience in the food industry; knowledge and proven experience with food safety programs and systems: GFSI (BRC or SQF preferred), internal auditing, cGMPs, HACCP, FSMA.
$68,000ExpandApply NowActive JobUpdated 5 days ago - UpvoteDownvoteShare Job
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Knowledge of cGMP, GxP, GAMP, and SDLC regulations, including 21CFR part 11 electronic records and electronic signatures, and good documentation practices with the ALCOA principles of data integrity, risk-based approaches to validation, Computer Software Assurance (CSA) principles.
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