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FDA resumes in Carnegie, PA

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Quality Assurance Management

Pittsburgh, PA, 15217
... Knowledge: FDA, 510(k), 21 CFR 820, ISO 13485, PMA, GLP, Risk Assessment, FMEA analysis, CAPA, IND. [pic] ACADEMIC HONORS . Recipient of the Dean's Fellowship for MS in Biomedical Engineering, Drexel University . Rank Holder for B.tech in Biomedical ... - 2013 Apr 18

Quality Assurance Manager

Pittsburgh, PA
... • Responsible for USDA licensing and FDA registration. • Authored plant Quality and Food Safety systems to include cGMP’s and HACCP. • Designed product test protocols. • Worked with customers on private label specifications and requirements. General ... - 2013 Mar 12

Home Health Quality Assurance

Pittsburgh, PA
... Communicated Adverse Events and Product complaints within the FDA regulatory framework including the creation and reconciliation of reports, managing deviations and working with agents across business units to maintain quality handling on behalf of ... - 2013 Mar 03

Quality Assurance Manager

Pittsburgh, PA
... I've served as an auditor on quality systems issues and FDA, regulatory requirements for domestic facilities. Prior to working in manufacturing, I worked for the American Red Cross Biomedical Services as a Quality Assurance Senior Associate for the ... - 2013 Feb 05

Manufacturing Development

Pittsburgh, PA
... BA/BE) studies Coordinating clinical trial drug manufacturing with CMOs Regulatory: Good understanding of cGMP, FDA regulations and ICH guidelines for industry Preparing Investigational New Drug (IND) application documents and knowledge ... - 2013 Jan 29

Quality Assurance Project Manager

Pittsburgh, PA
... Pittsburgh, PA April 2008 - Present *Manage and develop the Equipment department in a biotechnology, pharmaceutical and business environment *Comply with FDA (CFR 210-211), ISO (9001 & 17025), cGMP, OSHA, European, and other regulatory bodies ... - 2013 Jan 29

Sales Quality Assurance

Pittsburgh, PA
... capital improvements for iodine production to gain FDA approval for the first new nuclear agent within GE in 10 years. This agent is AdreView - I-123-mIBG - FDA approved in 10/08 Coordinated the R&D team to initiate development with Angiotensin-II ... - 2013 Jan 21

Quality Control Medical

Pittsburgh, PA, 15220
... SEPT ’12 – JAN ’13 • Performing laboratory testing to meet standards set up in PMO, Standard Methods for the Dairy Industry and FDA 2400 methods. • Responsible for running and interpreting results on the following tests: butterfats; total solids; ... - 2013 Jan 19

Project Manager Customer Service

Carnegie, PA, 15106
... and secured product FDA regulation • Maintain and cultivate highly complex client relationships and environments • Strong client facing skills: presentation, communication, influencing and negation EXPERIENCE iDL: Merchandising Solutions On-Site Sr. ... - 2012 Dec 18

Software Engineer Manager

Pittsburgh, PA
... Implemented GLP and FDA compliance regulations (HIPAA & 21 CFR Part 11) in LIMS implementations for various industries such as pharmaceutical, life- sciences, food & beverage and petrochemicals. Designed and developed an in-house customized issue ... - 2012 Dec 10
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