• Analyst, QC Microbiology

    Fujifilm (Holly Springs, NC)
    …preparation and review, managing project timelines, conducting qualification and validation protocols, and assisting management with training and on-boarding of ... ID systems (MALDI, MicroSeq) * Intermediate LIMS training * Knowledge or training of FDA regulations (cGMP, cGLP, cGDP) * Trackwise System training * Lean / 6S… more
    Fujifilm (05/02/25)
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  • Quality Assurance Data Review Scientist

    Cambrex High Point (High Point, NC)
    …conducts data review activities for data generated by GMP Analytical for validation of analytical test methods, testing of cleaning samples, raw materials, process ... Ensures compliance with company policies and SOPs as well as FDA and other applicable guidelines. Qualifications/Skills Fundamental understanding (experience is not… more
    Cambrex High Point (05/01/25)
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  • Sr Manufacturing Maintenance Tech - Night Shift

    BioFire Diagnostics, LLC. (Durham, NC)
    …and improves procedures and Preventative Maintenance Activities. + Adherence to FDA Regulations, GMP, ISO, HSE (OSHA), Department Procedures, and Manufacturing ... environment. + Proficiency in machining, welding, and fabricating. + Knowledge of change control, validation , and commissioning processes. #biojobs #LI-US more
    BioFire Diagnostics, LLC. (04/28/25)
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  • Manufacturing Quality Engineer

    CTG (Durham, NC)
    …quality engineering methodologies including Six Sigma, FMEA, DOE, MSA, and validation protocols + Support key plant projects and continuous improvement initiatives ... approve Project Design History Files + Author technical process documents compliant with FDA and ISO standards + Conduct internal audits to ensure quality system… more
    CTG (04/26/25)
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  • Lead Manager - IT Manufacturing Support

    Reynolds American (Winston Salem, NC)
    …or Agile Training/Certifications is a plus. + Regulatory Experience: Experience with FDA -relevant systems and/or processes and computer system validation . **WE ... ARE REYNOLDS AMERICAN-A member of the BRITISH AMERICAN TOBACCO GROUP** At Reynolds American, we are committed to our Purpose of creating A Better Tomorrow. This is what drives our people and our passion for innovation. **See what is possible for you at… more
    Reynolds American (04/25/25)
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  • Scientist 1, Global QC Analytical Development Raw…

    Fujifilm (Holly Springs, NC)
    …testing approaches, determine internal and external laboratory verification and validation needs, and provide technical support for troubleshooting new material ... compendial method oversight and ensure compliance with GMP guidelines, eg ICH, EMA, FDA , etc. * Supports and participates in regulatory audits and client inspections… more
    Fujifilm (04/17/25)
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  • Manufacturing Maintenance Tech 3 - Day Shift

    BioFire Diagnostics, LLC. (Durham, NC)
    …equipment reliability and efficiency + Ensure all maintenance activities comply with FDA regulations, GMP, ISO standards, and safety protocols + Utilize and maintain ... to detail and GMP experience (including knowledge of change control, validation , and commissioning processes) desired. + Adheres to documentation requirements in… more
    BioFire Diagnostics, LLC. (04/15/25)
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  • Facilities Services Specialist

    Herbalife (Winston Salem, NC)
    …Manufacturing, Planning, Product Development, QC, Safety, Sanitation, Sourcing, Training and Validation as it relates to Facilities and Engineering operation at the ... experience or similar job experience* 5+ years' experience in cGMP, FDA regulatory requirements* Experience supporting the development/tracking of project scope,… more
    Herbalife (04/10/25)
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  • Analyst, Business (SAP Production Planning)

    Revlon (Oxford, NC)
    …and implement the release of developments according to the Revlon validation procedures. + For those change requests requiring incremental spending, proactively ... SAP PP with at least 8+ years of configuration experience in an FDA -regulated environment + Technically skilled in ABAP, iDOCs, BAPIs, and other integration methods… more
    Revlon (03/28/25)
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  • Assoc, Process Eng, Sterilization

    West Pharmaceutical Services (Kinston, NC)
    …to developing and introducing process improvements, standards, life cycle management and validation in select process areas, helping to advance and transform West's ... operations; prefer SAP and MS Office applications. + Experience working with ISO9000, FDA and cGMP preferred + Understanding and experience in use of Lean… more
    West Pharmaceutical Services (03/25/25)
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