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Sr. Medical Writer/Associate Director, Medical Writing
PTC THERAPEUTICS - 2 reviews - South Plainfield, NJ 07080
In adherence with GCP, applicable regulatory requirements and guidance documents (e.g., 21 CFR Parts 312 and 314, EMA Clinical Trials Directives, ICH guidelines...
Quality Engineer CAPA Specialist
Thermo Fisher Scientific - 1,124 reviews - Bridgewater, NJ 08807
Proficient knowledge of CAPA practices in accordance with standards such as ISO9001, ISO 13485, 21 CFR 820 Experience with excel and QMS databases required;...
Laboratory Systems Administrator
Understanding of cGMP, cGxP, and 21 CFR part 11 for validated electronic data systems in an analytical laboratory environment....

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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Regulatory Affairs Manager

Expediem Services Group - Mahwah, NJ
$85,000 - $120,000 a year
Strong knowledge of quality system requirements specifcially ISO 13485 and FDA’s 21 CFR Part 820. U.S....
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Staff Quality Systems Specialist I

Becton Dickinson & Company - 545 reviews - Franklin Lakes, NJ 07417
Experience in high volume plastic molding and sterile medical device manufacturing, including validation and engineering support a plus 21 CFR Part 11 and /or...

CSV Lead

Arth Systems - Somerset, NJ
Thorough knowledge of cGMP regulations related to CSV including 21 CFR Part 11, and GAMP standards are required....
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Senior Product Quality Analyst

Orthoclinical - Raritan, NJ
QSR, CMDR and other international regulations per product, ISO 13485 standard, 21 CFR 200's). US - NJ - Raritan....

ARISg Technical Consultant

Katalyst Healthcares & Life Sciences - South Plainfield, NJ 07080
Good knowledge of Clinical and Safety process, Data Management, Safety Data Processing and applicable regulatory requirements (21 CFR Part 11, ICH-GCP, EMEA,...

Document Control Specialist

Mallinckrodt - 58 reviews - Hampton, NJ
Familiarity with the regulatory requirements associated with document controls (e.g., 21 CFR 820, 21 CFR 211, ISO 13485) preferred....

Regulatory Affairs Manager

Hopper & Associates - Mahwah, NJ 07495
$110,000 - $150,000 a year
Strong knowledge of quality system requirements specifically ISO 13485 and FDA’s 21 CFR Part 820. Regulatory Affairs Manager*....
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Manager, Quality Systems

Reed-Lane - Wayne, NJ 07470
Shared Management of Quality Assurance, Compliance and Validation in conjunction with 21 CFR Parts 210 & 211, Part 11, GMP and Good Manufacturing Practices....
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Complaint Analyst

Mallinckrodt - 58 reviews - Hampton, NJ
This position reports to the Sr. Manager, Product Monitoring. This position is responsible for opening and closing Commercial Complaints and for determining
Proofreader
At least 2-3 years’ experience in the pharmaceutical industry with knowledge of drug development, US electronic drug listing regulations (21 cfr 207) and US...
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QA RA Engineer
Katena Products Inc. - Denville, NJ 07834
Quality System Regulations (21 CFR Part 820, 21 CFR 1271), ISO 13485, EU Medical Device Directive (MDD 93/42/EEC)....
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