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Resumes 31 - 40 of 175 |
Bay Shore, NY, 11706
... a proven ability to communicate with the domestic (US-FDA, CDER/ CBER) and District Offices (General Inspection and Pre-Approval Inspection), DEA / EPA / OSHA / USDA) and international (MHRA / EMA / Health Canada, Russia, China) regulatory agencies. ...
- 2020 Nov 18
West Babylon, NY
... Clinical Research Training and Professional Experience Clinical Research Fastrack September 2020 Scottsdale, AZ 148 hours of training ICH GCP E6 R(2) FDA Regulations 21CFR 11, 50, 54, 56 and the Common Rule 45CFR46 Data Management Informed Consent ...
- 2020 Nov 05
Centereach, NY
... 2012 Working in production laboratory, synthesizing carbon-11 radiopharmaceuticals in accordance to GMP and FDA regulations -Preformed chemical synthesis of radiopharmaceuticals -Modernized workflow by implementing, calibrating and developing ...
- 2020 Oct 21
Wantagh, NY
... Quality Assurance Quality Control Quality Management Risk Management Validation Audits Six-Sigma Waterfall Agile SDLC/PDLC Quality Center ServiceNow SharePoint SAP FDA FAA SOPs ITIL CFRs 21 CFR Part 11 FAR 117 ISO 9001 (2008 2015) CAPA RCA ...
- 2020 Sep 22
Long Island, NY
... machine • Design and perform verification and validation test protocols for quality assurance • Gain comprehensive understanding of FDA regulations John Rogers Group, Northwestern University, Evanston, IL July 2018 – June 2020 Graduate Researcher • ...
- 2020 Sep 14
Smithtown, NY
... Performance of compressed air testing Has worked within BSL-2 and BSL-3 environments Excellent documentation skills Knowledge of OSHA regulations Knowledge of USP methods, BAM, AOAC, FDA, NSF regulations, cGMPs (21CFR211), and cGLPs HACCP Writing ...
- 2020 Aug 02
Merrick, NY
... service contracts Directed Customer Service to Global Distributors Directed Allocation and Fulfillment for all channels of trade – Ecommerce, Retail, Wholesale/Distributors Head of Import Compliance - assuring adherence with CBP and FDA regulations. ...
- 2020 Jul 09
Mineola, NY
... list and multiple procedures for efficient machine operation •Experience with medical device manufacturing compliant to FDA 21 CFR820 and ISO 9001, ISO 13485 Cummins – Seymour, Indiana June 2018-December 2018 Thermal/Performance Engineer •Worked ...
- 2020 Jul 08
Valley Stream, NY
... transfers • Familiar with FDA, ICH Guidelines and 21 CFR part 210 & 211, part-11 Part 820 and ISO 13485 • FAR and Recalls • Process validation • Review CMC section for IND,NDA and ANDA • Batch Record review • Stability Program including Clinical ...
- 2020 Jun 21
Roslyn Heights, NY
... Responsible for the operation of four (USDA & FDA) regulated sites, as well as the company’s overall Supply Chain Implemented lean manufacturing and focused on manufacturing excellence and profitability. Renegotiated supply contracts with major ...
- 2020 Apr 18