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Leads quality assurance for both molecular genetics lab and cytogenetics lab. Serves as primary quality liaison to TPMG IT, LIS Support systems and KPIT for ongoing and new issues. Interacts with TPMG Regional Quality and Compliance.
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The Director of Quality Initiatives will serve as a central point of supervision for quality initiatives with wide latitude to participate in programmatic Quality Improvement and Quality Assurance work across the CHS Medicine service.
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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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POSITION SUMMARY As the Director of Quality , you will be responsible for directing excellence in quality during the production cycle by providing technical leadership within the quality discipline, driving adherence to established standard operating procedures.
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We are currently seeking a dynamic, highly motivated, and experienced individual for the position of Associate Director of GMP Quality Control, who oversees GMP compliance of manufacturing, testing and release activities for SMPA, its partners, contract testing laboratories, and suppliers of drug substances and drug products used for investigational clinical trials and/or commercial phases.
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Associate Director, GMP Quality Control. Experience working in more than one product area (e.g. solid oral dose, injectables, combination products), and therapeutic area (e.g. oncology, urology, regenerative medicine) within Quality Control a plus.
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Advanced knowledge and use of software applications, including LC chromatographic analyses, statistical applications, and quality management systems (e.g. Veeva). The Associate Director ensures compliance with GMPs, SMPA procedures and applicable global Regulatory guidelines by providing oversight and management of the global contract testing laboratories in partnership with the Company's CMC Team. The Associate Director also participates in drafting and reviewing CMC sections of the IND, IMPD and BLA/NDA submissions.
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Review and approve Quality Events, Investigations, CAPA, Change Controls, and Complaints in eQMS. Contribute to product development by making recommendations for manufacturing controls, sampling and testing to ensure product quality and compliance with GMPs from development through commercialization.
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Participate, as needed, in audits of contract laboratory sites and support annual Risk Assessments as part of the Supplier Quality program. Experience in evolving GMP related quality systems, policies, and procedures to ensure compliance with evolving standards as well as improving the efficiency of related workflows.
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Quality leader and quality culture promoter within the global organization. Responsible for compliance with regulatory filings and therefore must have experience in a Quality Assurance and/or Quality Control function for marketed pharmaceutical products or clinical trial materials.
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8+ years of experience required, with relevant experience in biotech or pharmaceutical industry with most experience in a Quality role. Expertise in design of method validation, transfer, and stability studies consistent with regulatory, quality, and pharmaceutical best practices (e.g., USP, ICH.
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Strategic and tactical in the planning and execution of quality initiatives and activities. Provide quality management oversight of analytical activities with domestic and international contract manufacturing organizations and testing laboratories, and with internal and external partners.
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The role works closely and have high visibility with Executives, VP’s and Directors of Engineering, Infrastructure, SRE, Product Management and Customer Support to ensure overall software quality in development pipeline all the way to production regions, and to set the strategy for developing high-quality software to solve complex problems for our customers and users.
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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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CHI Franciscan Rehabilitation Hospital strives to maximize the health, function, and quality of life of those we serve through comprehensive physical medicine and rehabilitation programs. Certification preferred by APIC (American Practitioners of Infection Control), and NAHCQ (National Association of Health Care Quality.
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Title: director quality Company: Incendia
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