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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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Ensure that production personnel follows compliance of all Center activities with cGMP, Kedplasma DCOP’s (Donor Center Operating Procedures) and other Company standards and protocols to meet the regulatory requirements of the FDA, EMEA, Customer Specifications, and other regulatory bodies as required.
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Understanding and familiarity with FDA and European regulatory requirements, guidelines. The QA Documentation Control Specialist II is responsible for the maintenance of the cGMP controlled documentation system and for providing the various.
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Experience within cGMP/FDA regulated industry. Basic understanding of cell culture, cryopreservation, purification, and aseptic processing or lab technique. Production of blood component lots through cell culture, harvest, and cryopreservation.
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Extensive experience working in sterile manufacturing, cleanroom, and cGMP environments that meet FDA, ICH guidelines, local regulations, and industry best practices. Participate in regulatory inspections (e.g. FDA, DEA) as a Subject Matter Expert (SME.
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Our client, a global leader in biotechnology and innovation of therapies for rare and genetic diseases and life-threatening conditions is seeking a QA Documentation Control Specialist II that will be responsible for responsible for the maintenance of the cGMP controlled documentation system.
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Omeros’ lead MASP-2 inhibitor narsoplimab targets the lectin pathway of complement and is the subject of a biologics license application pending before FDA for the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy.
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Knowledge of FDA/cGMP regulations and chemistry or biology background is preferred. Ultradent, the global name in oral health is seeking a Formulator I to join our Formulations Department and work on Swing Shift (3:30 - 11:30 pm, Monday - Friday.
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FISI adheres to ISO and FDA regulations and operates dual cGMP manufacturing facilities in California, USA, and Tokyo, Japan. Knowledge of Cgmp, FDA regulations, and/or medical device manufacturing experience is required.
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This position is responsible for ensuring the end product is packaged per work instructions while adhering to cGMP requirements for packaging of Personal Care and OTC products in the contract manufacturing industry as required by FDA/EPA. This position works in a team environment to ensure the production requirements are met while observing all SOPs. Essential Functions: Follow instructions from team leader.
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Process Validation & Current Good Manufacturing Practices (cGMP), Food and Drug Administration (FDA), Drug Enforcement Agency (DEA), and other regulatory requirements. Process Validation & Current Good Manufacturing Practices (cGMP), Food and Drug Administration (FDA), Drug Enforcement Agency (DEA), and other regulatory requirements.
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Must have sound knowledge and experience in FDA regulated cGMP warehousing, Quality, and compliance environments. The Contractor Field QA Specialist role is stationed in Devens, MA and reports to the Senior Manager of QA Operations for the Devens SUF.
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Reviews and approves change controls for specification, manufacturing process, labeling, CAPA’s to ensure compliance with FDA and Health Canada requirements, including compliance with cGMP, and GDP requirements.
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Knowledge of cGMP regulations and FDA guidance applicable to biologics and cell therapy manufacturing. Understanding controlled temperature, humidity, and pest control monitoring for cGMP environments.
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Performs basic preparatory procedures on feed samples containing pharmaceutical ingredients according to FDA cGMP requirements. 75% Grinds feed mill samples and prepares fecal and gut samples as part of routine testing programs.
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