• Senior QA Validation Engineer

    Danaher Corporation (Chaska, MN)
    …test method, equipment, process, and/or design testing methodologies. + Knowledge of FDA regulations, ISO standards, and GxP guidelines. + Experience with Computer ... System Validation (CSV) and process validation It would be a plus if you also possess previous experience in: + Experience in IVD Medical device or Pharmaceutical Manufacturing + ASQ Certification Beckman Coulter Diagnostics, a Danaher operating company,… more
    Danaher Corporation (01/14/26)
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  • Senior/Executive Director - Dermatology Portfolio…

    Lilly (Indianapolis, IN)
    …of pharmaceutical industry regulations and compliance requirements (eg, PhRMA, FDA ). + Familiarity with medical affairs activities, including KOL engagement, ... medical education, and publication planning. + Excellent written and verbal communication skills, with the ability to convey complex scientific information clearly and concisely to diverse audiences + Strong analytical and critical thinking skills. +… more
    Lilly (01/14/26)
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  • Maintenance Mechanic

    Aerotek (Hazelwood, MO)
    …in technical matters. + Working knowledge of OSHA, GFSI, QF, USDA, and FDA regulations. **Why Work Here?** Join a startup company that offers tremendous growth ... opportunities. Be a part of a dynamic team within a cutting-edge facility. **Work Environment** The position is based in a food manufacturing plant, offering a flexible shift schedule and requiring adherence to safety and quality standards. **Job Type &… more
    Aerotek (01/14/26)
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  • Sr. QA Specialist

    Grifols Shared Services North America, Inc (San Marcos, TX)
    …+ Plan and conduct scheduled internal audits to assess compliance with FDA , ISO, MDR, and internal requirements. To include audit scheduling, investigation, and ... evaluation of audit observation and findings, reporting, follow-up, and confirmation of follow-up actions. + Pro-actively investigate, identify, and implement best in class Quality Systems practices and implement/manage improvement projects within the… more
    Grifols Shared Services North America, Inc (01/14/26)
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  • Principle Scientist

    Actalent (Madison, WI)
    …and Analyst software. + Knowledge of ICH or 28BMV regulatory guidance protocols and FDA internal standards. Job Type & Location This is a Permanent position based ... out of Madison, WI. Pay and Benefits The pay range for this position is $85000.00 - $110000.00/yr. Medical Plan* No Charge Laboratory Testing Benefit and physical therapy Dental Plan Vision Plan Flexible Spending Accounts (FSAs) Health Care FSA Dependent Care… more
    Actalent (01/14/26)
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  • Technician, Metrology

    Cole-Parmer (Vernon Hills, IL)
    …experience in a regulated/quality-controlled environment (ISO9001, ISO17025, ISO 13485, FDA ). Minimum Requirements/Qualifications: + Must have strong desire to ... service customers fully with unwavering commitment to high quality to meet requirements of ISO 17025, ANSI/Z540-1. + Experience in maintaining and following ISO17025 and ANSI Z540 related procedures. + Common knowledge and adeptness with non-routine… more
    Cole-Parmer (01/14/26)
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  • Senior Manager, Clinical Data Management

    Bristol Myers Squibb (Princeton, NJ)
    …with external vendors + Sound knowledge of Clinical Drug Development Process, FDA /ICH guidelines and industry standard practices regarding data management + Strong ... knowledge and experience of EDC systems (Medidata RAVE preferred); demonstrated knowledge of Microsoft Office skills and well versed in industry trends and emerging technologies supporting data collection + Strong project management; Exhibits expertise in… more
    Bristol Myers Squibb (01/14/26)
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  • Sanitation, Cheese Specialist

    Performance Food Group (Rice, MN)
    …and processing machines and work areas according Federal Department of Agriculture ( FDA ) regulations and ensuring quality standards are met and maintain the ... efficient flow of product through the production process. This job is responsible for maintaining the premises of the cheese processing room and storage facilities in a clean and orderly condition in compliance with the Sanitation standard operating procedures… more
    Performance Food Group (01/14/26)
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  • QC Manager Microbiology

    Actalent (Vernon Hills, IL)
    …QA on SOPs, investigations, CAPAs, and deviations. + Ensure compliance with FDA , USP, EU, and ISO guidelines. + Oversee media preparation, instrument validation, ... and calibration. + Analyze QC metrics and performance indicators for trending and batch release decisions. + Conduct internal audits, training, and team mentorship. + Communicate with cross-functional teams on data issues and resolutions. Essential Skills +… more
    Actalent (01/14/26)
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  • Director Biostatistics Oncology (Statistical…

    Astellas Pharma (Northbrook, IL)
    …Represent Astellas on all statistical matters in global regulatory interactions (eg, FDA , EMA, PMDA). + Guide preparation of statistical content for regulatory ... submissions, briefing packages, and health technology assessment (HTA) dossiers. + Lead the development of statistical components of payer evidence strategies, including indirect comparisons and external control methodologies. Innovation and Methodological… more
    Astellas Pharma (01/14/26)
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