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Grnalbuquerque
, IL, United States
Quality Assurance Manager Hoffmann Estates, IL Required Experience: 5+ years working in a GLP regulated environment 5+ years working in a GLP regulated environment Supervisory/Management experience preferred Required Education: Bachelor’s Degree (M.S. degree preferred) Job Description The Quality Assurance Manager is responsible for coordinat
Job Source: GrnalbuquerqueUniversity of Chicago
Chicago, IL, United States
Department BSD DFI - cGMP About the Department The Duchossois Family Institute (DFI) at the University of Chicago is using cutting-edge technologies and developing facilities to accelerate research and introduce novel interventions that optimize microbiome-mediated host defenses, with the goal of enhancing health. By developing new knowledge abo
Job Source: University of ChicagoGrnalbuquerque
, IL, United States
Quality Assurance Specialist/Sr. Specialist Hoffmann Estates, IL Required Experience: 3+ years working in FDA regulated environments 2+ years in a quality assurance or related role Required Education: B.S. degree; M.S. preferred, w/ industry (pharma or bio lab experiience) Job Description The QA Specialist/Sr. Specialist will be responsible
Job Source: GrnalbuquerqueRyan Specialty
Chicago, IL, United States
Position Summary: The Quality Assurance Director develops, implements and maintains a comprehensive quality management system. The role conducts audits and assessments of operational processes and implements quality improvement initiatives Location: Chicago - Illinois - Wacker What will your job entail? Position Summary: This is an excellent op
Job Source: Ryan SpecialtyXeris Pharmaceuticals, Inc.
Chicago, IL, United States
Overview: The Associate Director, Quality Assurance will provide cross functional quality assurance support to manufacturing, quality control, clinical and non-clinical operations. This role will be responsible for QA business processes supporting GMP, GCP and GLP compliance, regulatory inspection readiness, quality planning and continuous improvem
Job Source: Xeris Pharmaceuticals, Inc.Xeris Pharmaceuticals, Inc.
Chicago, IL, United States
Overview The Associate Director, Quality Assurance will provide cross functional quality assurance support to manufacturing, quality control, clinical and non-clinical operations. This role will be responsible for QA business processes supporting GMP, GCP and GLP compliance, regulatory inspection readiness, quality planning and continuous improvem
Job Source: Xeris Pharmaceuticals, Inc.Tempus
Chicago, IL, United States
Passionate about precision medicine and advancing the healthcare industry? Recent advancements in underlying technology have finally made it possible for AI to impact clinical care in a meaningful way. Tempus' proprietary platform connects an entire ecosystem of real-world evidence to deliver real-time, actionable insights to physicians, providing
Job Source: TempusMérieux NutriSciences
Chicago, IL, United States
As a trusted partner, our Public Health mission is to make food systems safer, healthier and more sustainable. Throughout our global network in 27 countries, we offer to our customers a wide range of testing and innovative solutions dedicated to preventing health risks related to food, environment and consumer goods. External growth has been a key
Job Source: Mérieux NutriSciencesChicago, IL, United States
Quality Assurance - GLP Bioanalytical Lab (from Manager up to Director level)
Company Summary: An international CRO, specializing in small molecules and large molecule bioanalysis, is currently seeking a driven, motivated, and multi-faceted QA professional, anywhere from the Manager to the Director level. The candidate will play a critical role in ensuring lab operations are in compliance with GLP requirements. The ideal candidate will have strong leadership skills, attention to detail, and a thorough understanding of GLP requirements.
This individual will be responsible for:
Developing and implementing a quality system to support bioanalytical lab operations.
Serving as a company SME on GLP requirements from a quality assurance perspective.
Leading and reporting inspections, data audits, quality systems audits, etc.
Develop, review, and authorize documents necessary to maintain GLP compliance.
Collaborate with management to stay informed about compliance challenges and communicate audit findings, facilitating necessary discussions.
Manage the controlled document system to ensure accurate and up-to-date documentation.
Oversee the quality aspects of sponsor visits and audits.
This individual should have the following qualifications:
At least 3+ years working in a GLP environment with at least 2+ years in a QA function
Deep familiarity with quality assurance systems in a bioanalytical lab - experience with ICH M10 guidelines for bioanalytical method validations
Strong understanding of regulatory requirements and quality standards applicable to pharmaceutical manufacturing (e.g., FDA regulations, GLP guidelines)
If you see yourself in this QA GLP Bioanalytical role and are interested, then please don't wait to apply.
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Email Alert for Quality Assurance Manager to Director - GLP QA jobs in Chicago, IL, United States
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