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Our core practice areas include vaccine research, development, and production; microbiology and infectious disease research; biodefense; clinical research; global health security; and HIV/AIDS programs.
$101,383 - $124,846 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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The Role Review and approve all batch records prior to production to ensure that they conform to requirements of cGMP and Clinical Trial Protocol. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market.
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Document control, archive, archival, archivist, doc control, qa, quality assurance, quality associate, quality specialist, quality assurance specialist, gmp, cgmp, gxp, mastercontrol, veeva vault, edms, document management system, pharma, biopharma, medical device, biotech, biotechnology, fda, quality systems, qms, eqms, clinical manufacturing, commercial manufacturing, novel pharmaceutical, novel drug, novel therapeutic.
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Maintain compliance with SOP, current Good Manufacturing Procedures (cGMP) and regulatory guidelines. This Is Who You Are: Part brand ambassador, part clinical technician. Team lead/Supervisor experience.
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Clinical Manufacturing Associate. Experience within cGMP/FDA regulated industry. Background to include an understanding and application within industry of biology, chemistry, medical or clinical practices.
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The Senior Quality Assurance Specialist provides Quality support for Petaluma site and ensures adherence to cGMP compliance in a regulated environment. Review and approve GMP documents (e.g., production batch records, clinical labelling records, lab batches, API and raw material specification, drug product specifications, analytical work order reports, standard test methods, standard operating procedures, protocols for method validation, method validation reports, stability protocols and stability reports, equipment IQ, OQ, PQ qualification protocols and reports, and equipment calibration documentation.
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Stay informed and knowledgeable about all compliance requirements originating from the cGMP, AAALAC, Joint Commission, DOH, CAP, risk insurance providers, Seattle Fire Department, and any other authorities having jurisdiction.
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Collaborate across the CMC function and with Quality Assurance to plan and implement the execution of cGMP activities in support of both clinical and commercial supply chain. Work with colleagues in CMC, QA, commercial, clinical, and regulatory affairs to ensure appropriate selection and oversight of vendors.
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The Hearth is the home of a custom-designed cGMP facility dedicated to AAV viral vector manufacturing and will host end-to-end manufacturing services to accelerate gene therapy programs from preclinical through clinical and commercial stage manufacturing.
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Significant experience working with ERP systems, specifically Materials Management, Supply Chain Management, Demand Planning, Inventory Management and Production Scheduling modules in a cGMP environment.
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To be considered for the Senior Manager role you must have a BS/BA in business or scientific subject area and 8 years of related experience in either cGMP manufacturing operations (clinical and/or commercial) or supplier management or equivalent combination of education and experience.
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This is a hands-on role responsible for daily on-the-floor activities in support of GMP systems for a clinical-stage cell therapy company. Coordinate warehouse operations in the cGMP facility including receiving, storage of raw materials in properly designated locations (e.g., raw materials, freezers (-20, -80C and LN2) and refrigerated locations), picking and component preparation (Kitting) for manufacturing, and product shipping.
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Part brand ambassador, part clinical technician. Our strong growth is creating great learning and career development opportunities throughout our company, and especially our donation centers. With donation centers and team members throughout the U.S., Octapharma Plasma, Inc. collects plasma to create life-saving medicines for patients worldwide.
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Catalent Pharma Solutions in San Diego is currently hiring a Manufacturing Technician I. The Manufacturing Technician I will be responsible for conducting cGMP manufacturing of solid oral and liquid oral pharmaceutical dosage forms for Phase I and Phase II clinical trials.
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Employee assistance program (EAP) Conduct basic screening procedures (e.g. reviewing health related documents, taking vital signs and performing finger sticks) There are so many ways Octapharma Plasma can enhance your life and your career.
$17ExpandApply NowActive JobUpdated Today
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