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FDA jobs in Hillsborough, NJ

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Clinical Manufacturing Associate

Cynet Systems Inc.  –  Warren, NJ, 07059
... Experience within cGMP/FDA regulated industry. Basic mathematical skills. Technical writing capability. Proficient in MS Office applications. Background to include an understanding and application within industry of biology, chemistry, medical or ... - May 01

ASSOCIATE II REGULATORY LABELING

TK-CHAIN LLC  –  Princeton, NJ, 08540
Job Description SUMMARY OF POSITION The Associate, Regulatory Labeling prepares, reviews and submits to his/her manager high-quality regulatory labeling submissions intended for the FDA within company timelines and in accordance with regulatory ... - Apr 07

Vice President Regulatory Affairs Quality Assurance

EPM Scientific  –  Green Knoll, NJ, 08807
... Oversee the preparation, review, and submission of PMA applications to regulatory authorities, including the FDA. Provide guidance and expertise on regulatory requirements, standards, and best practices related to PMA submissions. Collaborate with ... - Apr 28

HVAC Mechanic

System One  –  Monmouth Junction, NJ, 08852
... Responsible for all aspects of HVAC and refrigeration equipment maintenance while complying with cGMPs, SOPs, and FDA requirements Performs routine and complex work related to troubleshooting, repair, and upgrade of HVAC and refrigeration equipment; ... - Apr 27

CSV Consultant

Katalyst Healthcares & Life Sciences  –  Raritan, NJ, 08869
Responsibilities: Minimum 7 years' Experience in the Validating IT software systems like Quality Management System in Life Sciences industry Experience in FDA and/or Global regulated environment with good understanding of GxP standards like CFR 820 ... - May 02

Clinical Manufacturing Associate - Est

Cynet Systems Inc.  –  Warren, NJ
... Experience within cGMP/FDA regulated industry. Basic mathematical skills. Technical writing capability. Proficient in MS Office applications. Background to include an understanding and application within industry of biology, chemistry, medical or ... - May 02

Calibration Specialist

Mastech Digital  –  Raritan, NJ
... · Ensure site compliance with all local, state and federal regulations including and equivalent to Federal Drug Administration (FDA), Environmental Protection Agency (EPA), Occupational Safety and Health Administration (OSHA) as applicable. - Apr 28

Quality Control Biochemistry Analyst

GroupA  –  Hopewell, NJ, 08525
... You will be responsible for QC biochemistry laboratory assay validation and transfer activities to support GMP manufacturing, testing and release of material, intermediates and finished products under FDA/EU regulations, applicable International ... - May 03

Metrology Specialist

Sunrise Systems Inc  –  New Brunswick, NJ, 08933
... Demonstrated work experience in compliance with cGMP and FDA requirements, including Good Documentation Practices (GDP). Detail-oriented and well-organized with excellent communication skills in both verbal and written forms. Ability to work ... - May 04

CMC Senior Manager

Sunrise Systems Inc  –  New Brunswick, NJ, 08933
... regulatory documents (global registrations, including NDAs, MAAs and others, responses and supplements/variations) Knowledge of FDA, EMA and/or ICH guidelines and CMC regulations Experience in post-approval requirements Experience in developing CMC ... - May 04
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