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All duties are performed in compliance with FDA cGMP/cGTP requirements, American Association of Tissue Banks (AATB) standards, and Osiris Therapeutics Inc. standard operating procedures (SOPs.
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Read, understand, and comply with cGMP (Good Manufacturing Practices) and SOPs (Standard Operating Procedures), including general safety, lock outs and so on. Write, review, and revise SOPs (Standard Operating Procedures) and/or work instructions for cGMP (Good Manufacturing Practices) manufacturing of commercial product.
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Sr. Supervisor, Manufacturing Operations (Chicago, IL): Be responsible for oversight of pharmaceutical manufacturing processes; producing high quality pharmaceutical products in accordance with regulatory requirements to achieve the operations production plan; as well as oversee daily supervision of personnel on the efficient use of equipment and materials to produce quality products under cGMP in accordance with the production plan, including scheduling and resource coordination.
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An Operator II is proficient in the set-up, start-up, continuous operation and shutdown of the assigned manufacturing equipment and processes using adherence to Standard Work Instructions, Good Manufacturing Practices and current Good Documentation Practices.
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Review and oversee the development and/or revision of Standard Operating Procedures related to cGMP quality and regulatory compliance. Knowledge of cGMP regulations and current industry trends related to pharmaceutical products.
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Good Manufacturing Practices (cGMP) and Standard Operating Procedures (SOP) to produce a product. Forklift/order picker driving experience; reach lift truck, sit-down forklift, electric pallet.
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A proven record of technical problem-solving experience with standard operating procedures and cGMP analytical testing; most tasks will be non-GMP. Need someone to start ASAP. 100% onsite lab based role at Rahway,NJ.
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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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To ensure product quality, this role much adhere to standard procedures and cGMP. Adheres to standard operating procedures and cGMP. The Manufacturing Technician is responsible for the aseptic manufacturing of tissue-based (human and porcine) products for the regenerative market.
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Disconnect donors by removing the needle from the venipuncture site and dispose of all contaminated disposable equipment into a biohazard container. Ability to lift, tug, and pull up to fifty (50) pounds.
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Write, review, and approve technical CQV documentation including standard operating procedures, validation plans, execution plans, risk assessments, summary reports, URS, FRS, design specifications, testing protocols, and so on.
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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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Learns and maintains thorough familiarity and compliance with all state and federal regulations, FDapproved 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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La nostra gamma di prodotti comprende oltre 80 API generici prodotti secondo gli standard di cGMP. Il sito produttivo ospita oltre 300 dipendenti, organizzati in sette reparti dedicati a produzione farmaceutica, essiccamento, finitura e purificazione.
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The Stability Associate will participate in the QC Stability Study Program activities which includes designing and drafting stability study protocols according to ICH guidance for drug substance, drug product and reference standard, participate in range of quality control analytical activities such as analytical assay performance, and transfer of standard protein characterization methods.
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