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Resumes 51 - 60 of 648 |
Randolph, NJ
... 101, 110, 210, 211, 312 29 CFR AIB AMA ANSI API ASI ASME ASHRAE ASTM BOCA cGMP CAA CWA CERCLA DEA DEEP DEQ DOT EO 12866 EPA EU FDA FMEA FQPA Food Safety FOIA FSMA FSSC 22000 Gluten Free GMP HACCP HCS ISO ISO 14001 ISO 45001 ISO 9001 Kosher LEED NEC ...
- 2023 Nov 09
Edison, NJ
... FDA-ICH (International Council of Harmonization) guidelines GCP (good clinical practices) guidelines, GVP (good pharmacovigilance practices). Proficient in MS Office (MS Word, MS Excel, Power Point) Professional Experience Drug Safety and ...
- 2023 Nov 06
Paterson, NJ
... for plant operations ●Implemented cross training program plant wide for all operators ●Review all documentation met all FDA and company guidelines ●Complete all operator reviews and training programs ●Oversee all nonconformance issues that arise ...
- 2023 Nov 03
Paterson, NJ
... of product documentation ●Coordinates, assigns, tracks, and assesses multiple documentation projects ●Was involved in documentation during various stages of the validation lifecycle, in accordance with FDA regulations, including 21CFR Part 11. ...
- 2023 Nov 02
Rockaway, NJ
... Responded to FDA queries and received 30 approvals in first three years. In 2020, company received warning letter from FDA and could not obtain any additional approvals; however, almost 50 additional approvals will be approved once facility issues ...
- 2023 Oct 27
Flanders, NJ
... MEDCO PRESCRIPTION SERVICES, (Formerly Merck Medco), Parsippany, NJ Staff Pharmacist / Lead Pharmacist of Control/Narcotic Department Discussed adverse drug events with patients during customer service calls and submitted FDA MedWatch reports based ...
- 2023 Oct 08
South Plainfield, NJ, 07080
... There are 5 pools created in Integrated ADaM datasets This includes submissions to: 1.The US Food and Drug Administration (FDA), 2.The European Medicines Agency (EMA) 3. The Pharmaceuticals and Medical Devices Agency (PMDA). Actively involved in ...
- 2023 Oct 06
East Orange, NJ
... with the hiring of Clinical Sites to the reconciliation of TMF contents and document progress, to sending documentation to the FDA for approval) ● Monitoring of volunteers visits and working with the Medical Writers ● Knowledge and the ‘know how’ of ...
- 2023 Sep 27
Ridgewood, NJ
... Documents for Clinical Trials as per ICH GCP Guidelines • Knowledge in GCP standards, CDISC standards (CDASH, SDTM), FDA and ICH guidelines and recommended CDM best practices CAREER CONTOUR As Manager -Clinical Data Management • Successfully ...
- 2023 Sep 21
Hopatcong, NJ
... Able to follow OSHA and FDA regulations as well as SOPs and Good Manufacturing Practices (GMP). Hard working, dependable and safety conscious team player who strives for quality and achieves consistent production results.! Professional Experience ! ...
- 2023 Sep 08