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FDA resumes in Emmaus, PA

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Project Management Application Development

Lansdale, PA
... Project 6: ClinPharm and CTS (Clinical Trial Suite) Application Upgrade, Support, and Retirement from 2009 – 2019 Description: CTS reduced the cycle time of clinical trials and regulatory (FDA) submissions to improve the accuracy and efficiency of ... - Apr 14

Supply Chain Business Analyst

Frenchtown, NJ
... Common Technical Documents (eCTD) submissions for submitting applications, amendments, supplements, and reports to FDA's Center for Drug Evaluation and Research, Activity & Support Diagrams, validation and testing of clinical trial systems ... - Apr 09

Front Desk Office Assistant

Bethlehem, PA
... • Food Service • Food Handling • Culinary Experience • Food Preparation • Retail Sales • POS • Merchandising • Warehouse distribution • warehouse associate • Baking • FDA regulations • Basic knife skills • Dock worker (1 year) • Warehouse worker (1 ... - Apr 08

Analytical Development Molecular Biology

Lansdale, PA, 19446
... • Conducted assessment of the IND/BLA filings in compliance with FDA regulatory and pharmacopeial guidelines. • Supervised and trained technical staff. Shin-Yi Du, Ph. D., Resume – Page 1/2 P A G Postdoctoral Fellow (2019 – 2021) Northwell Health - ... - Mar 24

Product Management Market Development

Hellertown, PA
... with researches from academic institutions conducting clinical trials targeted to expand and promote legally cleared FDA clinical claims Supported the International cooperative group “Colon Tumor NBI Interest Group” (CTNIG) in the development ... - Mar 15

Pharmaceutical SME RE: PV., Clinical research, Medical monitoring

Schwenksville, PA
... Jul-2012 – Jul-2014 Adverse Experience Reporting Coordinator III (contract position) ·Determines, on the basis of SOP’s and FDA regulations, the prompt or periodic classification of each adverse experience contained in the reports received for Merck ... - Mar 09

Graphic Designer Social Media

Perkasie, PA
... • Designed website and FDA-compliant labels for a line of food products, Chiliboss. The website and labels helped them gain distribution with major retailers. PROFILE Graphic Designer and Illustrator / 1996 - Present Partner and Designer ... - Jan 29

Machine Learning Data Science

Chalfont, PA
... Management, Validation and FDA Compliance, Leading High Performance Teams, CTFA Cleaning/Sanitizing validation, P&G Auditor training, cGMP seminar, PMI (project management Institute) and Lean manufacturing seminars, 6 Sigma, Veeva Vault seminars. ... - Jan 19

Inventory Control Production Supervisor

Allentown, PA
... From either the customer, FDA or Kane. Also responsible for any recalls which needed to be completed within two (2) hours from initial notification. Just completed the first quarter inventory. out of 914,595 cases counted. we had one anomaly of 20 ... - Jan 11

Software Program Management Strategy

Lansdale, PA
... Piramal Pharmaceuticals (Teva supplier) - Pennsylvania QAIT Architect 07-2022 to 02-2023 In less than six months, I built a new, highly efficient risk-based CSV program in preparation for an FDA audit and product release. I Developed twenty-seven ... - 2023 Dec 18
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