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Overview The Quality Assurance (QA) Auditor provides compliance and quality improvement support to the manufacture of phase 1/2a Investigational New Drug, Biologics manufacture and facility operations.
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Develop, lead, direct, update, reassessment, verification and periodic validation of FSQA programs including HACCP Program, Sanitation Standard Operating Procedures, Pest Control, Good Manufacturing Practices, Approved Supplier Program, Foreign Material Control, Plant Sanitation, Chemical Control, Product Quality Assurance, FSQA Customer Complaints, Food Defense and Security.
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The Director, Clinical, Preclinical, and Diagnostic Quality Assurance ensures GLP, GCP, CAP/CLIA compliance with ImmunityBio Standard Operating Procedures (SOPs), ICH guidelines and US FDA regulations, and Preclinical and Clinical study protocols/plans.
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Administer the implementation of food safety and quality assurance (FSQA) programs including hazard analysis and critical control point (HACCP) program, sanitation standard operating procedures, pest control, good manufacturing practices, approved supplier program, foreign material control, plant sanitation, chemical control, product quality assurance, FSQA customer complaints, and food defense and security.
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Food Safety & Quality Assurance Collaboration Provides corporate support for the activities of business unit Food Safety and Quality Assurance (FSQA) teams to ensure consistent processes, methods and standards, and compliance with all regulations.
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Comprehensive knowledge of biologic and drug development process, pharmaceutical technology, manufacturing processes, GMP, quality assurance & management and related issues, preferably in the areas of cell and gene therapy.
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Develop and direct Food Safety & Quality Assurance (FSQA) support/evaluation programs and inspection/audit procedures to ensure compliance of products and processes to corporate and regulatory requirements at a Sysco Specialty Meat and/or Seafood Company with multiple shift operations or over multiple facilities within a region.
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Perform quality assurance review and approval of investigation, deviations, OOSs/OOTs, Change Controls, CAPAs and. Create product quality documentation system by writing and updating quality assurance procedures.
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Prepare for all Company Quality Audits, FSSC (Food Safety System Certification), IBWA, FDA, Dept of Agriculture, Military, and Kosher. BlueTriton Brands Quality Assurance Manager Hollis , Maine Apply Now BlueTriton is a leading provider of spring and purified water products - the name behind your favorite bottled water brands.
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5-10 years meat and/or seafood industry (as appropriate) FSQA Management experience at a federal CFIA/FDA meat and/or seafood processing plant (as appropriate) acceptable instead of a degree. Participate with Sysco Specialty Meat Company (SSMC) and/or Sysco Specialty Seafood Company (SSSC) personnel (some companies have combined seafood and meat operations) in the ongoing development, improvement and support of new and existing product quality and FSQA processes including supplier and customer interaction on FSQA matters.
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Review audits and ongoing monitoring of DEA compliance, FDA compliance, PDMP compliance, OSHA compliance, HIPAA and HITECH compliance, and Boards of Pharmacy regulatory compliance, and compliance with client KPIs. Partner with the CCO to the design and maintenance of quality programs, including but not limited to QA plans, inspection procedures, work instructions, training, deviation investigations and CAPA management, facility mapping and validation projects.
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AtriCure’s Isolator Synergy Ablation System is the first medical device to receive FDA approval for the treatment of persistent Afib. AtriCure’s AtriClip Left Atrial Appendage Exclusion System products are the most widely sold LAA management devices worldwide.
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Manages the Cyclotron Facility with emphasis on Operations and Quality Assurance. Quality Assurance Manager page is loaded Quality Assurance Manager Apply locations Chicago, IL time type Full time posted on Posted 5 Days Ago job requisition id JR24829 Department.
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The QA Manager will be designated as both the FDA Preventive Controls Qualified Individual (PCQI) and the SQF Practitioner / Implementer and will be responsible for the implementing and maintaining the Food Safety / SQF program for that location, including all records and quality procedures.
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Be a regional resource on new procedures / methods / requirements from industry or regulatory that involves quality assurance. Director of Quality Assurance & Food Safety. Six plus years of quality assurance and supervisory experience.
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