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Laboratory Systems Administrator
Understanding of cGMP, cGxP, and 21 CFR part 11 for validated electronic data systems in an analytical laboratory environment....
Labeling & Registration Manager
Bayer - 1,623 reviews - Whippany, NJ
Your tasks and responsibilities The primary responsibilities of this role, Labeling & Registration Manager, are to: Create and manage labeling in accordance
FPGA Design Engineer
Blue Danube Systems - Township of Warren, NJ
Digital filter, DUC/DDC, CFR, digital equalizers, DPD, AGC, fixed point DSP. The candidate will work as part of a radio design team interacting closely with...
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Quality Engineer

EPM Scientific - Bridgewater, NJ
$70,000 - $100,000 a year
Knowledge of ISO 9001, ISO 13485 and/or 21 CFR part 820. $70000 to 100000 + bonus + excellent benefits*....
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ETQ Quality Engineer

Themesoft INC - 5 reviews - Summit, NJ
$60 an hour
Ensure continued system compliance to applicable electronic QMS system regulations, including 21 CFR Part 11. $60/hr....
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Scientific Application Specialist

virpietech - New Brunswick, NJ
Experience with Computer Systems Validation, working knowledge of 21 CFR Part 11. Scientific Application Specialist*....
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Scientific Application Specialist

Eclaro Business Solutions - New Brunswick, NJ
Experience with Computer Systems Validation, working knowledge of 21 CFR Part 11. Work with the project manager to drive the project, including all SDLC...
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"ETQ Quality Engineer"

Cloud Source Inc - Summit, NJ
Ensure continued system compliance to applicable electronic QMS system regulations, including 21 CFR Part 11....
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Validation Analyst, CSV

Clintuit Inc - Somerset, NJ
$60,000 - $75,000 a year
Maintain up to date knowledge of evolving regulatory requirements, availability of current/new techniques, cGxP, 21 CFR Part 11, 210, and 211, and other...
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Principal Scientist

Bristol-Myers Squibb - 606 reviews - Princeton, NJ 08540
Knowledge of GLPs, 21 CFR Part 58, Bioanalytical Guidance (FDA, EMA), Immunogenicity Guidance (FDA, EMA) is desirable....

Systems Analyst

Tris Pharma - 13 reviews - Monmouth Junction, NJ 08852
Fundamental understanding of Qualifications, Validations, and CFR Part 11 required. Tris Pharma, Inc....
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Project Manager

Klus Pharma Inc. - Monmouth Junction, NJ
Working knowledge of FDA regulations (e.g., 21 CFR 314.50 and 314.94 and 21 CFR 201 and 208) and applicable FDA guidance....
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QA Documentation Associate

Tulex Pharmaceuticals - Cranbury, NJ
Familiarity with the CFR and GMP requirements is a plus. Assign the code numbers for raw materials, finished products, in-process materials and art work....
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Manager, Regulatory Affairs
Knowledge and experience with 21 CFR and cGMPs. Responsible for ANDA Submissions including:....
Senior Manager, Quality IT Systems - North America
Strong knowledge of regulations (such as GMP, GAMP5, 21 CFR Part 11) governing IT activities in both domestic and international healthcare regulatory...

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