• Fill/Pack Operations Supervisor (DPI)

    United Therapeutics (Research Triangle Park, NC)
    …pulmonary arterial hypertension ( **PAH)** . Today, we have six FDA -approved therapies that treat PAH, pulmonary hypertension associated with interstitial lung ... goal‑setting, and open communication to hit daily deliverables and maintain GMP compliance. You will collaborate closely with QA, warehouse, manufacturing, and… more
    United Therapeutics (08/10/25)
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  • QA Specialist, DSM (Project QA)

    Fujifilm (Holly Springs, NC)
    …with 0 years' relevant experience * 1-3 years' experience in a GMP environment * Experience in Validation, cGMP manufacturing operations and/or Quality oversight, ... in an FDA regulated facility **Preferred Requirements** * 2+ years of experience in GMP Quality Assurance and/or similar role * Experience and working knowledge… more
    Fujifilm (08/08/25)
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  • Analyst, QC Microbiology

    Fujifilm (Holly Springs, NC)
    …discipline * 0-2 years of basic GLP laboratory experience * Understanding of GMP , GLP, GDP requirements * Knowledgeable in basic sciences and Microbiology laboratory ... Biology * 2+ years of Intermediate experience in a GMP QC Microbiology Laboratory, knowledge of all compendial test...* Intermediate LIMS training * Knowledge or training of FDA regulations (cGMP, cGLP, cGDP) * Trackwise System training… more
    Fujifilm (08/01/25)
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  • QA Specialist, DSM (2 openings, 0600-1800)

    Fujifilm (Holly Springs, NC)
    …with 0 years' relevant experience * 1-3 years' experience in a GMP environment * Experience in Validation, cGMP manufacturing operations and/or Quality oversight, ... in an FDA regulated facility **Preferred Requirements:** * 2+ years of experience in GMP Quality Assurance and/or similar role * Experience and working knowledge… more
    Fujifilm (07/15/25)
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  • Sr. Quality Director

    Transylvania Vocational Services (Brevard, NC)
    …+ Integrate current quality standards with food safety processes (eg, HACCP, GMP , internal audits, sanitation). + Maintain and enhance systems for document control, ... including food safety, sanitation, and continuous improvement. + Ensure compliance with USDA, FDA , OSHA, SQF, OU, and other regulatory bodies. + Act as liaison with… more
    Transylvania Vocational Services (07/10/25)
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  • Operations Manager - Night Shift

    Lilly (Concord, NC)
    …consumable and supplies definition and procurement, training resource development, GMP documentation creation, and management of people, materials, product flows ... of basic requirements of regulatory agencies such as the FDA , EMEA, DEKRA, and OSHA, or other similar groups...responsibilities not specifically described in the job description. For GMP purposes, the job description should be updated for… more
    Lilly (06/21/25)
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  • QA Data Integrity Specialist

    Astellas Pharma (Sanford, NC)
    …(as applicable). + Participate and represent the company in regulatory (eg, FDA , EMA, DHHS, etc.) inspections and audit activities conducted by third-party and ... in a regulated industry. + Working knowledge of US and International GMPs, FDA /ICH Guidance, and best practices in a biotech manufacturing and testing environment +… more
    Astellas Pharma (08/23/25)
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  • Quality Assurance Engineer I

    Herbalife (Winston Salem, NC)
    …investigative skills * Knowledge of Good Manufacturing Practices, Food and Drug Administration ( FDA ) regulations ( FDA 21 CFR - Part 111/117) and documentation ... + 3 years' experience in Quality related field * Knowledge of basic GMP and QA/QC in the food, nutraceutical or pharmaceutical industry **Education:** * Bachelor's… more
    Herbalife (08/08/25)
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  • Engineer III, Validation

    ThermoFisher Scientific (Greenville, NC)
    …(Mon-Fri) **Environmental Conditions** Adherence to all Good Manufacturing Practices ( GMP ) Safety Standards, Office **Job Description** **Title: Engineer III, ... and systems. + Host and coordinate regulatory inspections performed by the FDA , MCA, and other regulatory agencies. + Defend policies, procedures, rationales, and… more
    ThermoFisher Scientific (08/08/25)
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  • Senior Microbiology Analyst

    Glenmark Pharmaceuticals Inc., USA (Monroe, NC)
    …microbiological testing and environmental monitoring (EM) in compliance with cGMP, USP, FDA , and internal quality standards. This position is in a fast-paced, ... FDA regulated environment in the Pharmaceutical Industry. This role...and implements these actions within the laboratory. + Performs GMP review of test data to ensure that test… more
    Glenmark Pharmaceuticals Inc., USA (07/24/25)
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