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Ambler, PA
... by 75% Global Director of Lean Six Sigma ABBOTT LABORATORIES 2003 - 2005 Implemented a world-class Business Excellence program (DMAIC, Lean Manufacturing, and DFSS) into Abbott Diagnostic’s business within the confines of GMP and FDA oversight. ...
- Jul 02
Philadelphia, PA
... Designed new packaging and patient information and medical guide inserts while adhering to strict pharmaceutical regulations and FDA guidelines • Assisted with NDA submissions by preparing artwork using Adobe Illustrator and Photoshop and Indesign. ...
- Jun 30
Springfield, PA, 19064
... Science, Engineering, Technology & Telecom Services) – West Chester, PA 10/2021 – 09/2023 Provided oversight of vendor documented changes to ensure FDA regulatory compliance for Johnson & Johnson/Ethicon/US Hospital MedTech family of companies. ...
- Jun 20
Lansdale, PA
... records and process-related documentation (process maps, job aids, project trackers, checklists) ●Comprehensive knowledge of FDA drug regulations and GCP/GCLP regulations ●Tracked compliance issues in Quality Management System (QMS), policies, and ...
- Jun 20
Camden, NJ
... Validated databases install for various applications to satisfy FDA requirements. Project managed to apply Oracle security patches for all databases. Addressed globalization Oracle character sets issue. Propose solutions for global applications. ...
- Jun 05
Feasterville, PA
... December 2003 Talent Acquisition Manager GTM recruiting for identifying, sourcing, and hiring senior-level software engineers, data scientists, product managers, and technical program managers for the Electronic FDA Submission process for new drugs. ...
- Jun 03
King of Prussia, PA, 19406
... • Ensured all SDLC activities follow industry regulations and standards such as FDA 21 CFR Part 11, and EU Annex 11, supporting regulatory inspections and audits. • Performed validation scripts according to predefined protocols and documented ...
- May 30
Doylestown, PA
... I documented them and forwarded them on to the FDA if appropriate. I also determined if compensation was valid and apologized for their experience. Enumerator April 2010 - June 2010 US Census Department Doylestown, Pennsylvania I went door to door ...
- May 29
Philadelphia, PA
... • Knowledge of ICH Q7, 21 CFR Part 11, US and EU FDA, USDA, EH&S, and cGMP compliances and regulations. Mar 2018 – Jul 2018 Catalent Pharma Solutions, Quality Systems Management Training Specialist ● External and internal audits, employee trainings, ...
- May 28
Media, PA
... ● Implemented safety protocols, training dock and yard teams to meet strict FDA, USDA, and OSHA standards. ● Met rapid shipping deadlines and reduced spoilage rates by maintaining fluid movement from dock to warehouse. Warehouse Shipping Supervisor ...
- May 20