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Establish, Maintain and Improve GxP Quality System including, but not limited to: Deviations, CAPA, Change Control, Risk Management, Inspection Readiness, Product Complaints, Recall/Mock Recall, Internal Audit/Self-Inspection, Supplier Quality Management (incl AVL, QAG and Audit Management), Auditor Qualification, OOS/OOT, CSV, Data Integrity, Training and Document Control.
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Experience in risk management, tech transfer, validation, analytics, and microbiology and/or chemistry, within a GMP environment. Develops and deploys the quality systems (e.g., management review, CAPA, design control, process control) that ensure products conform to defined requirements.
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Provides leadership in all areas of the Quality System, including, but not limited to Root Cause Analysis, CAPA, Nonconforming Material Investigations and Reporting, Deviations, Change Control, Supplier Qualifications, and Audit support functions (internal and external.
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We are seeking an innovative and highly motivated individual to join our team as the Manager of Quality Control at our GMP manufacturing facility located in South San Francisco, CA. This position will work with the Quality Control team in supporting our efforts in the GMP manufacturing of cellular therapy products.
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Acts in a support capacity for critical QMS processes such as non-conformances, complaint management, field corrective actions, risk management, design control, CAPA, document and change control, training, batch release, auditing and validation.
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Oversee GMP compliance within cleaning, disinfectant, safety equipment inspections, work orders and pertinent tasks utilizing the client’s Computerized Maintenance Management System (CMMS) Assist with investigations of RCA/CAPA events.
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The Metrology Compliance Specialist supports the Metrology Services Department as a part of a rapidly expanding GMP Manufacturing Operation. CAPA System: Utilize this Quality system to evaluate identifiable factors to solve problems diverse in scope and implement continuous improvement corrective and preventive actions for system level improvements.
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Maintain the implementation and development of the facility's HACCP, SSOP, GMP, CAPA pre-requisite programs. Support and partake in 3rd Party audits (SQF, Non-GMO, Organic, Customer, FDA, Kosher.
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Assist management as a primary contact for 3rd party pest control, chemical supplier, and microbiological lab contracted service providers. Lead team meetings with QA team and Plant management teams. Associates' or Bachelor's degree in a science discipline or 1-3 years of experience in a Quality assurance role in a food manufacturing facility.
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Performs investigations and completes CAPA in response to deviations. Analysis of dry product stability and finished product samples according to the assigned specifications, analytical methodology and protocols in a GMP laboratory setting with emphasis on attention to detail and accuracy of execution.
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QA Issuance, Review and Approval of manufacturing production batch records in support of 300 BMK manufacturing operations Perform walkthroughs and other support activities of Analytical Science and Process Development to ensure compliance with applicable GMPs/GLPs. Review of GMP/GLP documentation from manufacturing and/or Analytical Operations, which can include logbooks, and test records.
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The manufacturing of oligonucleotide APIs in a GMP environment. Work with Manufacturing Management and Quality to resolve manufacturing problems including drafting quality documentation (CAPA, deviation, change control, etc.
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Lead effective communications within the GPT, by interacting with other GxP QA functions (GMP/ IMP QA, Audit Compliance, Quality Management System [QMS] QA, PV/MA Quality) and in close collaboration with CAPA Manager.
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This role leads complaint/CAPA investigations, supplier quality improvement actions, operations production and process control improvements, and product and service quality improvements with the use of statistical techniques and other accepted quality principles.
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Previous knowledge of oligonucleotide synthesis, HPLC, UF, conjugation, and lyophilization is advantageous. Actively involved in aspects of technology transfer and scale-up of oligonucleotide manufacturing processes delivered from Manufacturing Technical Services into Manufacturing.
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