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Maintain compliance with SOP, current Good Manufacturing Procedures (cGMP) and regulatory guidelines. Maintain compliance with SOP, current Good Manufacturing Procedures (cGMP) and regulatory guidelines.
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Transfers and Introduces technology of cell therapy-based and therapeutic protein processes into manufacturing collaborating extensively with Scorpion’s Process Development group to develop cGMP-compliant, clinical-scale production processes.
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Is a boutique biologics CDMO providing cGMP manufacturing, bioanalytical, and process development services for protein modalities. is a boutique biologics CDMO providing cGMP manufacturing, bioanalytical, and process development services for protein modalities.
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The RII operates a complete cGMP/GLP production facility to produce PET radiopharmaceuticals for human clinical and translational research. This position requires the successful candidate to be an adept, hands-on chemist with experience in organic, inorganic, analytical, or radiochemistry, preferably with experience in short-lived radioisotopes.
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Perform decommissioning activities and final reports for equipment, systems, utilities, facilities and/or manufacturing/packaging process for pharmaceutical, biotech and medical devices industries in accordance with cGMP requirements.
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Perform processing, packaging and labeling of cord blood product, associated cord blood sample(s), according to organizational and regulatory (AABB, FACT, FDA, ISO, and cGMP/cGTP) procedures and standards as needed.
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Monitors all systems and activities to ensure that source plasma manufacturing is performed consistently according to current Good Manufacturing Practices (cGMP), the Shire Quality System, and other applicable regulations for a plasma center.
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Team lead/Supervisor experience. 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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Assist in scale-up efforts in pilot plant for cGMP and non-cGMP small molecule synthesis. 2 years: Familiarity with one or more of the following analytical techniques: NMR, TLC, HPLC, IR, LC/MS.
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Plasma Collection Center Quality Assurance Oversight: (80%) Reviews operational records to ensure they are complete, accurate and compliant with cGMP requirements. Employees must also maintain complete and accurate records, in accordance with cGMP.
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Ensures compliance with quality, safety, regulatory requirements, and cGMP guidelines. CGMP/Documentation: Performs all functions according to Good Manufacturing Practices (cGMP) and company Standard Operating Procedures (SOP.
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Follows all Occupational Safety & Health Administration (OSHA), Clinical Laboratory Improvement Amendments (CLIA), current Good Manufacturing Procedures (cGMP), and internal company procedural and personnel policies and SOPs.
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Operation of laboratory instruments including automated chemistry modules, purification, and analytical instrumentation for radiopharmaceutical production. Assist the facility director in developing, improving, and maintaining protocols, various applications, and licenses as required for routine radiopharmaceutical production.
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Under the direction of the Quality Manager, the Product Quality Assurance Coordinator is responsible for ensuring products are being produced in a manner that meets all cGMP (Current Good Manufacturing Practice) and Product Specification criteria.
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Demonstrated understanding of plasma center operations. Conducts monthly quality assurance audits for critical control points and key elements for the systems related to donor suitability, source plasma collection, sample collection, plasma storage, product release, quality assurance, and employee training program.
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