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ElevateBio is looking for a Viral Vector Manager, QA Operations to join their growing Quality Group at our BaseCamp facility in Waltham, MA. In this role, the Manager will be primarily responsible for providing Quality oversight over execution of clinical cell and gene therapy manufacturing for cGMP compliance through on the production floor interactions, review and approval of batch related documents, and events.
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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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Sound knowledge of cGMP practices as applicable to process development, scale up, technology transfer, formulation development, and Manufacturing. Provide expertise for the scale up, tech transfer, and validation, of upstream cell culture and viral vector unit operations to internal and external partners in support of clinical/commercial manufacturing of products.
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Experience with quality systems, aseptic technique, cGMP document review, quality investigations, CAPA, Change Control and MasterControl preferred. College Degree and at least five to eight years cGMP experience in a pharmaceutical manufacturing company or equivalent combination of education and cGMP experience in a required.
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Maintain compliance with SOP, current Good Manufacturing Procedures (cGMP) and regulatory guidelines. 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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Understanding of cGMP/GLP and GDPs practices and EHS requirements of pharmaceutical lab and production environment. We design, supply, and service a range of water systems and monitoring equipment in industries ranging from pharmaceutical to food and beverage applications, and from microelectronics ultrapure water to municipal water and industrial wastewater treatment.
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Provide input into GCP Quality and Compliance Council regarding the QMS, RACT, Quality Plans and Regulatory Health Authority inspections status and results, including escalation of overdue CAPA commitments.
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Apply Quality Systems: Event and CAPA Management System, Document Management System, Learning Management System, Change Control System and new technologies. Apply Quality Systems: Event and CAPA Management System, Document Management System, Learning Management System, Change Control System and new technologies.
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Ability to learn, understand, and apply specific knowledge in order to develop, review, and approve design, quality, and manufacturing documentation such as design input, design verification, design validation, process validation, quality plans, risk management, CAPA, NCR, Complaints analysis, standard operating procedures, inspection procedures, etc.
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Expertise in process failure mode and effects analysis (pFMEA) and corrective and preventive action (CAPA) Requirements and desired experience: Bachelor’s degree in Biomedical Science, Biochemistry, Molecular Biology, Bioengineering, Chemical engineering or related fields preferred.
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Oversee all aspects of Quality Management System (QMS) processes including Change Control, Deviations, CAPAs, and Task Writes, ensuring compliance with internal SOPs, FDA, and cGMP regulations.
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Drive CAPA, deviation, risk analysis, and change control management processes. I am working with a client in the cell therapy field who are expanding their QA team and looking for an individual with expertise in GCP/GLP to support their QMS. The role is on-site in Burlington.
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Related experience with Biopharma cGMP manufacturing processes. 2+ years of experience in the field of plasmid DNA, mRNA, proteins manufacturing services or cell and gene therapy at a commercial CDMO.
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From vegan food to resource-efficient buildings to solar cells, we develop sustainable solutions that change the future. Bachelor of Science in biology, chemistry, biochemistry, microbiology or similar relevant education.
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Familiarity with general chemistry, mathematics, microbiology and cGMP clean room operations is a plus. Ensures compliance with cGMP and safety requirements. Innova Solutions offers benefits( based on eligibility) that include the following: Medical & pharmacy coverage, Dental/vision insurance, 401(k), Health saving account (HSA) and Flexible spending account (FSA), Life Insurance, Pet Insurance, Short term and Long term Disability, Accident & Critical illness coverage, Pre-paid legal & ID theft protection, Sick time, and other types of paid leaves (as required by law), Employee Assistance Program (EAP.
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