• QA Specialist ( Batch Record Review)

    Regeneron Pharmaceuticals (Rensselaer, NY)
    We are currently looking to fill a Quality Assurance Specialist position. This position performs activities supporting dispositioning product and/or raw materials ... advice in alignment with QA policies + Reviewing completed records and batch sheets and working with other departments and communicate internally (Tarrytown, Raheen)… more
    Regeneron Pharmaceuticals (02/04/25)
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  • Senior Quality Assurance Area Specialist

    Novo Nordisk (Durham, NC)
    …help us make what matters. The Position Main duties include review of batch reports & release of incoming materials, deviations, change controls, review & approval ... Relationships Manager, Quality Assurance. Essential Functions + Ensure plant systems batch release & relevant quality processes are compliant with regulations +… more
    Novo Nordisk (03/08/25)
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  • Analytical Quality Assurance Specialist

    Glenmark Pharmaceuticals Inc., USA (Monroe, NC)
    …from a Quality Assurance perspective, and act as primary reviewer of QC data for batch disposition . The AQA Specialist must be well organized and detail ... Analytical Quality Assurance Specialist Department: Analytical QA Location: Monroe, NC START...pharmaceutical company. POSITION SUMMARY: The Analytical Quality Assurance (AQA) Specialist will work with the Quality Control team to… more
    Glenmark Pharmaceuticals Inc., USA (03/18/25)
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  • Senior GMP Quality Specialist

    Kelly Services (Somerset, NJ)
    …to ensure sample integrity and compliance with regulatory requirements. + ** Batch Disposition Decisions** : Make final approval/rejection decisions on ... **Quality Assurance Specialist - Pharmaceutical- Somerset NJ** **Summary of Essential Functions:**... batch disposition , ensuring compliance with quality standards and regulatory requirements.… more
    Kelly Services (03/11/25)
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  • QA Operations Specialist

    Actalent (Philadelphia, PA)
    …Operations Specialist I supports Quality Assurance lot release and disposition activities, including process observation, batch record review, and completion ... of lot release documentation. The Specialist I also supports Quality Assurance initiatives such as...batch history files for QA Operations and Lot Disposition . + Provide real-time, on-the-floor support for manufacturing production… more
    Actalent (02/20/25)
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  • Quality Specialist , Analytical QA

    Endo International (Rochester, MI)
    …talented individuals to join our team. **Job Description Summary** The Quality Specialist , Analytical QA provides the required Quality & Compliance direction during ... clinical trial material and registration batches for development products. Provides disposition and release for clinical trial materials and registration batches.… more
    Endo International (01/10/25)
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  • Document Control/Archivist Specialist I,…

    Abeona (Cleveland, OH)
    …This position is also responsible for document archival and retention post product disposition . The Specialist I, Quality Assurance will report to the ... JOB TITLE SPECIALIST I, QUALITY ASSURANCE - QUALITY OPERATIONS Department...for select SOPs. + Compile, organize, and label all batch -related documents into a final product lot disposition more
    Abeona (01/30/25)
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  • Specialist III, Manufacturing Technical…

    Catalent Pharma Solutions (Harmans, MD)
    …** Specialist III, MTO** will provide support to Manufacturing Associates to meet batch record review/ disposition schedule to adhere to lot release dates. The ... **Manufacturing Technical Operations Specialist III** **Summary:** _Our FDA-licensed, state-of-the-art CGMP manufacturing...and revising GMP documents such as SOPs and Manufacturing batch records. **This is a full-time on-site position,** **M-F… more
    Catalent Pharma Solutions (03/13/25)
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  • Sr. Specialist , QA Operations

    Bristol Myers Squibb (Warren, NJ)
    …and Supply Chain Operations. + Apply knowledge of quality processes, including batch record review, material disposition , triaging of deviations, investigations, ... in their personal lives. Read more: careers.bms.com/working-with-us . **Position: Sr. Specialist , Quality Assurance Operations** **Location: Warren, NJ** The **Sr. … more
    Bristol Myers Squibb (03/20/25)
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  • Quality Specialist I - Records - 2nd Shift

    ThermoFisher Scientific (Cincinnati, OH)
    …**A Day in the Life:** + Provide Quality expertise and oversight of the batch disposition process which includes assessments of documentation to assure quality ... applicable to biologics or pharmaceuticals. + Knowledge of Quality oversight of batch disposition . + Excellent organizational skills and analytical and… more
    ThermoFisher Scientific (03/16/25)
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  • Senior Manufacturing Compliance Specialist

    Fujifilm (College Station, TX)
    **Position Overview** The Senior Compliance Specialist owns all manufacturing CAPAs, change controls and deviations. Leading all manufacturing deviation ... functional groups including Quality Assurance to support 'on-time' release and disposition of batches and other post-execution activities. **Company Overview** The… more
    Fujifilm (01/07/25)
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  • QA Principal Compliance Specialist

    Sanofi Group (Framingham, MA)
    **Job Title:** QA Principal Compliance Specialist , Operations **Location** : Framingham, MA **About the Job** We deliver 4.3 billion healthcare solutions to people ... quality, and efficacy of our products. As the QA Principal Compliance Specialist , you'll provide quality support and direction to Manufacturing, Quality Control, and… more
    Sanofi Group (03/15/25)
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  • Manufacturing Specialist

    Catalent Pharma Solutions (Harmans, MD)
    …to assist in technical knowledge transfer. + Assists manufacturing associates to meet batch record review/ disposition schedule to adhere to lot release dates. + ... **Manufacturing Specialist ** **Summary:** _Catalent, Inc. is a leading global...and revising GMP documents such as SOPs and Manufacturing batch records. + Participates and represents manufacturing in cross-functional… more
    Catalent Pharma Solutions (03/06/25)
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  • Specialist , Quality Assurance

    Boehringer Ingelheim (Fremont, CA)
    …equipment, HVAC, etc.), warehouse, manufacturing processes, inspection, labeling and packaging, batch record review, batch disposition , new product ... compliance and adherence to regulated QA activities for cGMP operations. **Sr Specialist , Quality Assurance** + Requires a Bachelor's or higher degree preferably in… more
    Boehringer Ingelheim (01/24/25)
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  • Document Specialist

    Adecco US, Inc. (Bridgewater, NJ)
    …is assisting a client in **Bridgewater, NJ** in their search for a **Document Specialist ** . The Document Specialist is a vital contributor to the department's ... all documents are current, accurate, and easily accessible. The Document Specialist will review production records meticulously to maintain compliance with industry… more
    Adecco US, Inc. (03/19/25)
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  • Specialist QA - Multiple Positions

    Kelly Services (Juncos, PR)
    …you find a job that works for you. How about this one?** We're seeking ** Specialist QA ** to work for one of our top **Biotechnology Industry client at Juncos, ... experience + Quality Professional with Manufacturing Process Audit and Batch Record Review experience. + Knowledge or to be...cGMP's and compliance + Bilingual (English & Spanish) The ** Specialist QA** will be responsible for review and approve… more
    Kelly Services (03/13/25)
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  • Quality Assurance Operations Specialist II

    Gilead Sciences, Inc. (Foster City, CA)
    …recommendations related to manufactured products. + Review and approve master batch records, labels, specifications and other pre-production documents for clinical ... FDA and international health authority requirements + Review executed production batch records, environmental monitoring data (as required), analytical data, and… more
    Gilead Sciences, Inc. (03/13/25)
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  • Principal Specialist , Quality Operations

    Boehringer Ingelheim (St. Joseph, MO)
    **Description** The Principal Specialist of Quality Operations provides real-time Quality Assurance support in Operations ensuring compliance with USDA, EU ... periodic assessments to maintain a state of audit readiness, real-time batch record review, 4-eye verification, calculations, sample control and delivery. +… more
    Boehringer Ingelheim (03/04/25)
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  • QA Specialist II, QA Validation

    Fujifilm (College Station, TX)
    …not limited to: + Standard Operating Procedures + Analytical Methods + Disposition certificates + Batch Production Records + Corrective Action/Preventive Action ... **Position Overview** The Quality Assurance (QA) Specialist II, QA Validation, under general direction, will be responsible for review and/or approval of basic and… more
    Fujifilm (01/04/25)
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  • QAO Specialist I

    CSL Behring (Kankakee, IL)
    …floor to ensure compliance to cGMPs. Real time review of batch records, including critical processing steps with production floor presence. Responsibilities: ... in necessary research to determine root cause, corrective/preventative actions, product disposition , and using the investigation tools provided by QAO Management. +… more
    CSL Behring (03/07/25)
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