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For the various levels you must have the following:Associate QC Micro Analyst: 0-12+ months of experienceQC Micro Analyst: 12-18+ months of experienceSr. Micro QC Analyst I: 4+ years of experiencePrior GMP experience in Microbiology related to drug substance (bulk) or drug product (fill/finish) manufacturing is preferred.
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1 plus year of GMP and FDA/USDA experience. Biology, environmental science, agriculture, QC/QA. Previous Food Manufacturing or HACCP/Food Safety Experience is a plus. 1 plus year of GMP and FDA/USDA experience.
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Chemistry, cleanroom, fda, mixing, gmp. Produce silicone-based formulations using various materials preparation techniques and mixing protocols. Making base bath, cleaning laboratory glassware and packing material mixing kit.
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Awareness and adheres to all FDA, GMP, BATF, EPA, OSHA and employer standards and guidelines. JOB DESCRIPTION Description:•Prepare process and finished product samples; perform analytical testing using instrumental, wet chemistry procedures, and record results using computerized data systems.
$22.93 - $25.08 an hourFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Pharmaceutical development, analytical development, quality control, CMC regulatory, GMP, ICH guidelines, FDA, analytical chemistry, organic chemistry, physical chemistry. Thorough understanding and working experience in innovative drug development and manufacturing concerning GMP, quality systems, ICH guidelines, FDA, EMA, and associated regulatory requirements.
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Knowledge of GMP, PC, OSHA, FDA, and USDA regulations strongly preferred. Continuous Improvement, TPM, Lean, Six Sigma, or other experience with the implementation of High Performing Work Systems.
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Thorough understanding and working experience in drug substance development and manufacturing with respect to GMP, quality systems, ICH guidelines, FDA, EMA, and associated regulatory requirements.
$205,000 - $225,000 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Experience in FDA/EMA regulations in biopharmaceuticals or cell therapy manufacturing is preferred. Working knowledge and/or ownership of the following quality systems: Change Control, CAPAs, Deviations, Management Monitoring and Self Inspection auditing, QA reporting, and approval of GMP documentation.
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Thorough understanding of food safety regulations and quality assurance standards (e.g., HACCP, GMP, SQF.) Food audit certification preferred (USDA, FDA, Merieux Certification, etc.) The company provides a comprehensive turnkey waffle program to over 40,000 customer locations throughout North America and has been operating for over 85 years Our well-established geographic footprint provides coast to coast coverage in the U.S. and a global distribution partner network servicing customers across the U.S. and in 45 countries.
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Responsibilities of the position include establishing and maintaining quality systems and compliance oversight to ensure the facility, utilities, equipment, and computer systems meet cGMP and Civica compliance requirements at the onset of building the facility leading to successful U.S. Food and Drug Administration (FDA) approval of the facility and the ongoing introduction and approval of new medications.
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Responsible for remaining current with GMP/GLP/GDP, ICH, USP, and FDA guidelines, industry standards, and trends that apply to current and future Cell Therapy Development operations and products.
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Assure compliance with all applicable quality, safety and regulatory standards (FDA, BSI, GMP) Assure compliance with all applicable quality, safety and regulatory standards (FDA, BSI, GMP.
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This candidate should have in depth knowledge of food safety regulations (ex: FDA, USDA, GMP etc) and quality management systems (HAACP, SQF). We find inspiration in our ability to create solutions, through the science and craft of freeze drying or lyophilization, that improve the lives of individuals and communities around the globe.
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Technical knowledge and guidance towards GMP compliance during triage/troubleshooting activities. deviations, product non-conformities, and GMP investigations to ensure compliant resolution and adherence to current Good Manufacturing Practices (cGMPs.
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Perform QC chemistry laboratory assay validation and transfer activities to support GMP manufacturing, testing and release of material, intermediates and finished biological products (monoclonal antibodies) under FDA/EU regulations, applicable International Regulations, BeiGene processes and procedures.
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