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Project Manager Management

Elkton, MD, 21921
... Moyer, PMP PROJECT MANAGER 717-***-**** *******@*****.*** Elkton, MD 21921 Project Manager with over 20 years’ experience in cross-functional project management and business change management for regulated industries including US FDA, DoD, and ... - Aug 28

Pharmaceutical Technician

Paterson, NJ
... ●In-depth understanding of Federal Regulations Title, including FDA, DEA, and the Cosmetic Act for manufacturing. ●Knowledgeable with process Protocols, SOP’s, cGMP’s with following batch records, OSHA Safety regulations. ●FIFO with materials used, ... - Aug 28

Human Resources Employee Relations

Indianapolis, IN
... Australian Gold/New Sunshine Manufacturing: 2015 – March 2023 Plant Manager – 2021 – March 2023 Oversee the development and establishment of procedure and process to comply with FDA, GMP, and cGMP Standards. Including process flow, facility design, ... - Aug 28

Scrum Master Project Manager

Monmouth County, NJ
... Played key role in winning Pfizer’s Quality Team Award for custom SharePoint and Documentum back-end used for FDA submission tool which improved Pfizer’s global pharmaceutical portfolio’s compliance. SANOFI-AVENTIS PHARMACEUTICALS (FULL-TIME) 08 ... - Aug 27

Clinical Research Trial

West Palm Beach, FL
... • Patient-Centered Medical Strategy • Regulatory & Compliance (FDA, GCP, ICH) Key Achievements • Supported FDA approval of Biogen’s Aduhelm (Alzheimer’s) through Phase I & III clinical trials. • Contributed to the development of Lundbeck’s Vyepti ... - Aug 27

Project Management Quality Assurance

Rocky Mount, NC
LinkedIn Profile Personal page at iubix.com +1-252-***-**** ***.*@*****.*** Professional Summary As a Certified GAMP Professional with extensive experience in FDA regulations, I specialize in risk-based approaches for remediation, QMS upgrading, ... - Aug 27

Regulatory Affairs Medical Device

Parsippany, NJ
... Proven ability to navigate the complexities of FDA regulations, manage project risks, and facilitate efficient regulatory processes. Seeking to leverage my expertise in regulatory affairs, compliance, and project management as Manager, Regulatory ... - Aug 27

Senior Quality Engineer

Waterford, MI
Lori Reinke PH: 248-***-**** Email: ********@*****.*** Accomplishments Knowledge of standards including ISO/IATF 16949, ISO 13485, ISO 26262, ISO 9001, ISO 14001, MIL HDBK 217, FDA/GMP, FMVSS, USCAR Obtained Lab accreditations – IATF 16949, VCA (EU ... - Aug 27

Patent Attorney Design Engineer

Washington, DC
... 39.Pharmaceutical biotech patent action, supporting claims to FDA exclusivity rights, brand and generic ANDAs. Relativity. DTI Global, Washington, DC; legal consultant for Quinn Emanuel (03-05/2015). 40.Pharma/Healthcare prime vendor agreements ... - Aug 27

Software Engineer Scrum Master

Pottstown, PA
... GAAP, SOX GDRP, GxP, ERP, PCI, SOC1, SOC2 FDA regulations, ISO and MILSTD standards FDA 21 CFR Part 11, GxP, and EU Annex 11 Identity Governance and Administration (IGA) Identity and Access Management (IAM) Product Owner Business and Financial ... - Aug 27
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