• Quality Specialist

    CSL Plasma (Raleigh, NC)
    …to monitor facility compliance with CSL procedures and policies, cGMP, OHSA, FDA , and other regulations, as applicable, and develop center responses for ... regulations and laws to include, but not limited to: ADA, Civil Rights, EEOC, FDA , GHA, HIPAA, and OSHA. 16 Maintain confidentiality of all personnel, donor and… more
    CSL Plasma (08/09/25)
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  • Quality Documentation Specialist

    Kelly Services (Wilson, NC)
    …review, approval, revision, and archival processes to ensure compliance with FDA /EMEA regulations. + Partner with internal teams including Learning & Development ... within the pharmaceutical or biologics industry. + Strong knowledge of FDA /EMEA regulations and GMP standards. + Hands-on experience with electronic document… more
    Kelly Services (08/08/25)
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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 ... procedures. * Proven track record to be self-motivated as well as to work collaboratively in a team-based environment is required. * Understands the importance of group thought, information sharing, collaboration and appropriate challenges to status quo *… more
    Herbalife (08/08/25)
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  • Engineer III, Validation

    ThermoFisher Scientific (Greenville, NC)
    …and systems. + Host and coordinate regulatory inspections performed by the FDA , MCA, and other regulatory agencies. + Defend policies, procedures, rationales, and ... + Demonstrated scientific writing skills and knowledge of cGMPs and FDA /industry expectations. + Ability to achieve goals and resolve sophisticated technical… more
    ThermoFisher Scientific (08/08/25)
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  • Logistics Coordinator-Night Shift

    BioFire Diagnostics, LLC. (Durham, NC)
    …controlled documents in accordance with company policies and regulatory agency (eg, FDA and ISO) requirements. + Provide assistance with the review and revision ... to work as part of a team with minimal supervision. + Knowledge of FDA and/or GMP regulations preferred. + Prior ERP experience preferred. + Prior Microsoft Office… more
    BioFire Diagnostics, LLC. (08/08/25)
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  • Associate Director Quality Assurance, Data…

    Glenmark Pharmaceuticals Inc., USA (Monroe, NC)
    …including, but not limited to, 21 CFR Parts 11, 210, and 211, and FDA data integrity guidance KNOWLEDGE, SKILLS AND ABILITIES: Education: Bachelor-s degree or higher ... results + Experience with pre-submission audits + Experience with FDA data integrity Leadership/Managerial attributes: + Collaborative mind-set + Management… more
    Glenmark Pharmaceuticals Inc., USA (08/08/25)
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  • Clinical Research Nurse- Endocrinology

    UNC Health Care (Hendersonville, NC)
    …clinical care for patients enrolled in a clinical trial while adhering to all FDA , OHRP and GCP guidelines and regulations. This position has a central role in ... ongoing consent process is performed and documented in compliance with FDA , International Conference on Harmonization Good Clinical Practice (GCP), institutional,… more
    UNC Health Care (08/08/25)
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  • Change Control Systems Specialist

    Biomat USA, Inc. (Research Triangle Park, NC)
    …Responsibilities:** + Ensures compliance with Food and Drug Administration ( FDA ) regulations and all policies, guidelines, and standard operating procedures ... and Abilities:** + Strong knowledge of Food and Drug Administration ( FDA ) regulatory requirements for good manufacturing practices. + Demonstrated spreadsheet and… more
    Biomat USA, Inc. (08/08/25)
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  • Post-Doc Research Associate

    University of North Carolina- Chapel Hill (Chapel Hill, NC)
    …Lineberger Comprehensive Cancer Center. The position is part of UNC's new NIH / FDA -funded Center for Tobacco Regulatory Science and Health Equity. We are looking ... broad theme of the UNC Center is building the science for effective FDA regulation of and communication about tobacco products disproportionately used by priority… more
    University of North Carolina- Chapel Hill (07/31/25)
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  • Sr. Operations Supervisor

    Grifols Shared Services North America, Inc (Goldsboro, NC)
    …all state and federal regulations, US Food and Drug Administration ( FDA )-approved Standard Operating Procedure Manual, Occupational Safety and Health Administration ... highest production standards in accordance with Federal and State regulations, with FDA approved Standard Operating Procedure Manual, OSHA, CLIA and cGMP. + Attends… more
    Grifols Shared Services North America, Inc (07/31/25)
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