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FDA jobs in Middlesex, NJ

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Job alert Jobs 1 - 10 of 481

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

Product Security Engineer

Atlas  –  New Brunswick, NJ, 08933
... and security goals for the orthopedics portfolio of products Develop security designs for new products Develop security designs for existing products, including post-marketing studies for medical devices that the FDA may have conditionally approved. ... - May 02

Quality Assurance Manager

Breckenridge Pharmaceutical, Inc.  –  Berkeley Heights, NJ, 07922
... systems, QA/QC Testing /Audit program, and Quality/Compliance decisions related to the Company’s ANDA products, as well as its products subject to OTC Monographs and FDA or other industry-accepted standards for Dietary Supplements and Medical Foods. ... - Apr 25

Lead Automation Engineer

Azzur of CA  –  Rahway, NJ
... Ensure compliance with regulatory requirements (e.g., FDA, EMA, GMP) and industry standards (e.g., ISA-88, ISA-95) for automation systems and processes. Develop and implement procedures and protocols for system validation, change control, and ... - Apr 26

Senior Regulatory Affairs Associate

Breckenridge Pharmaceutical, Inc.  –  Berkeley Heights, NJ, 07922
... Under the direction of Regulatory Affairs management, participate in drug development from early stage development through final formulation, ensuring compliance with principles of Quality-by-Design, cGMP, and FDA rules and regulations Support new ... - Apr 10

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

Aesthetic Area Sales Manager

Top Candidate Search Group  –  Morris Township, NJ, 07961
... Innovative technology using compact Lasers for 36 FDA indications. Description: Medical Device Aesthetic lasers Selling Capital equipment to Dermatology, Plastic Surgeons and Medical Spas Fast growing Sales organization, nice Culture! Company has ... - Apr 25

Quality Assurance Manager, External Manufacturing

EPM Scientific  –  New Brunswick, NJ, 08933
... Strong knowledge in FDA regulations (including 21 CFR Part 210, 211, 820). Benefits: Hybrid structure Base Salary and Bonus Stock - May 03
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