FDA resumes in New Castle, DE

Morton, PA
... Bristol-Myers Squibb, Hopewell, NJ March 2004 – May 2006 System Test Lead - Accenture ●Applied FDA 21 CFR Part 11, GCP, GMP and SOPs in the validation and implementation of in-house and COTS software applications to Oracle Clinical Trial and ... - 2020 Sep 08

Bear, DE
... Directed integration of multi-tier FDA clinical trials application for pharmaceutical client, receiving bonus and award for success. Earned Gold Certified Partner status from Microsoft and served as SME for sales efforts and client’s Windows/AD ... - 2020 Aug 02

New Castle, DE
... ●Managed and trained up to 25 staff members and clinical personnel for cross-functional duties, specific assignments, and operations according to and in compliance with SOPs, FDA regulations and ICH/GCP guidelines to meet project goals. ●Considered ... - 2020 Apr 27

Wilmington, DE
... Created IQ, OQ protocols and performed PQ testing 12 years of pharmaceutical MES out to Cloud manufacturing industry experience working with FDA and cGMP regulations and writing application codes to PLCs, SCADA, Wonderware, POMS,SAP and MES server ... - 2020 Mar 19

West Chester, PA
... Counsel individuals on the importance of FDA regulations. Maintained daily outputs determine by the operation schedule. Responded to quality issues in the form of a corrective action EDUCATION: West Chester University: West Chester, PA. B.A. ... - 2019 Aug 02

Newark, DE
... Lead technical staff for conducting GLP studies based on FDA guidelines. EDUCATION Institution Years Field Degree Capital Medical University (CMU) 9/2004 - 5/2007 Neurobiology Ph.D. Capital Medical University (CMU) 9/2000 - 5/2003 Pharmacolgoy M.S. ... - 2019 Jul 16

Middletown, DE
... Knowledgeable of cGMP, FDA, DEA and cGLPs. Developmental Chemist, Revlon Inc., 1996-2001 Received and interpreted assignments, developed and implemented dissolution studies. Prepared mobile phases for sample analysis and ran samples on HPLC and GC ... - 2019 May 05

Broomall, PA
... TED-Ed video and script production with over 140,000 views on U-Tube Clinical trial investigator brochures and product launch documentation Regulatory filing dossiers with FDA and EMA for NDAs, INDs in biologics and NCEs Production and Q/C editing ... - 2019 Apr 15

West Chester, PA
... • Maintained current knowledge of FDA Regulations 21CFR 803, 21 CFR 820. • Selected to assist in the training of a new complaint management system roll-out. • Selected to support another division in processing complaints. • Selected to attend The ... - 2019 Jan 11

Bear, DE
... Food and Drug Administration (FDA) and has been prescribed to several thousands of patients in the United States Monitor regulatory activity to maintain compliance with records and document management laws Worked in the quality assurance/quality ... - 2018 Nov 07