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Allentown, PA
... Created and automated FDA Auditor Profile report. This report was used to create a profile of the FDA auditor for use by BD site team. CSV files were extracted from an outside vendor database into an automated process which created a comprehensive ...
- 2023 Dec 07
Norristown, PA
... Assisted with FDA submissions of ISE and ISS with extensive graphs, tables, and listings. Led validation of TLF and analysis data . Worked in therapeutic areas of oncology, cardiovascular, diabetics studies, and blood pressure reductions. AUXILIUM ...
- 2023 Dec 06
Reading, PA
... Needle, label and packaging reconciliation to comply with company and FDA standards. RECEPTIONIST Reading Pediatrics - Reading, PA April 2010 to September 2010 As a front desk receptionist I greeted and checked patients in and out, scheduled ...
- 2023 Dec 01
Collegeville, PA
... Reviewed clinical processes and FDA compliance records. Scheduled document production coordinated outside counsel on both corporations and collected technical and commercial data. Managed all communications with Analysts and all vendors and clients ...
- 2023 Nov 20
Berwyn, PA
... Responses to FDA queries IP claims and disclosures Clinical Study Reports (CSRs) Working on RAPS certification Presentations and posters Informed Consent Forms KEY ACCOMPLISHMENTS • Led publishing for 3 pipeline products, facilitating successful ...
- 2023 Nov 17
Coplay, PA
... o Coordinated with FDA inspector to maintain optimal quality and health standards. o Ensured standards for quality, customer service, health and safety issues are met. JS JOHN SOUSA EMAIL: ad04i9@r.postjobfree.com TELEPHONE: 484-***-**** 3 o Handled ...
- 2023 Nov 13
Pottstown, PA
... Regulatory Submissions Manager with BRIO Consulting Group Worked on migration and clean-up project of MedWatch forms (FDA 3500A) and other safety reports (PSURs, etc.) Pfizer, Inc., Collegeville, PA November 2010 – April 2012 Consultant for ...
- 2023 Nov 11
Macungie, PA
... Attended 3 FDA audits Received Cardinal Health Chairman award for validation services. Managed staff of 5 Validation technicians. EDUCATION 01/2011 Bachelor of Science: Management University of Phoenix - Tempe, AZ 07/2007 Large Account Management ...
- 2023 Nov 09
Lansdale, PA
... Skilled in general orthopedic instruments and routinely contributes to submitting medical device reports (MDR) to the FDA. Professional Experience: Millenium Software, Inc- Olympus America, Inc. August 2023 – Present Quality Analyst Using Pivot ...
- 2023 Sep 03
Allentown, PA
... Research Scientist, Clinical Immunology, Swiftwater, PA 1997-2001 Developed statistical approach for the analysis of assay data resulting in FDA approval of the assays. Transferred assays into new laboratory on site. Managed contractors responsible ...
- 2023 Sep 01