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Philadelphia, PA
... Annex 15 Qualification and Validation and applicable Guidance ●United States Food and Drug Administration (FDA) 21 CFR Parts 11, 50, 54, 56, 312, 314, 801,803, 807, 812, 814, and 820 ● (Canada) Health Canada ●Pharmacovigilance Safety Associate ...
- Apr 13
Holland, PA
... ŸEnsuring the software remains compliant with Regulatory Body requirements, specifically FDA 21 CFR, Part 11 PHARMANET, Princeton, NJ 8/2006-7/2008 IT Manager, Data Management, Validation, QC and Testing Responsibilities: ŸDirected the day to day ...
- Apr 03
Voorhees, NJ
... over multiple gene therapy testing units (adenovirus, rAAV, lentivirus) • Engaged in GMP audits from regulatory bodies (FDA, EMA, PMDA) and client audits • Wrote and reviewed standard operating procedures (SOPs) • Trained new study directors and ...
- Mar 31
Springfield, PA, 19064
... Responsible for the manufacturing of all home care trans fill oxygen and completion of all FDA documentation to maintain accurate lot number tracking and manufacturing licensure. Job Responsibilities Pick, stage, process, package, document and ...
- Mar 26
Philadelphia, PA
... Collaborated with Employee Relations Coordinator to ensure swift and accurate approval and processing of settlements, grievances, PDAs, and FDA's within designated timeframes. Provided daily reports on leaves of absences, approved ADA accommodations ...
- Mar 25
Philadelphia, PA
... • Followed strict FDA regulations for products to be submitted for production. • Proofed and verified colored proofs and Standards. Graphic Designer/Copy Writer 2005-2008 News-Line Publishing, King of Prussia, PA • Designed Ads for sales department. ...
- Mar 23
Philadelphia, PA, 19146
... Svyatoslav Milovanov experience regarding dealing with complex issues of submissions to regulatory authorities (FDA, EMEA etc), member of ACRES with founder of FDA - (Former FDA commissioner Greg Koski) customs issues, patient recruitment has always ...
- Mar 21
Philadelphia, PA
... • Perform duties in strict compliance with FDA, QSR GMP regulations. • Routinely utilize measurement and calibration techniques. • Conduct visual and dimensional inspections of machined components in accordance with published inspection instructions ...
- Mar 21
Havertown, PA
... ability to talk with individuals at all levels • Very knowledgeable with CRO, Clinical trial processes, HIPAA and other myriad FDA regulations and compliances Professional Experience Diagnostic Solutions Laboratory 2013-2022 Director, New Business ...
- Mar 15
Philadelphia, PA
... TJC) U.S Food and Drug Administration (FDA) Center for Disease Control (CDC) Occupational Safety and Health Administration (OSHA) Association for the Advancement of Medical Instrumentation (AAMI) Einstein Montgomery Medical Center, East Norriton Pa. ...
- Mar 11