FDA resumes in Downingtown, PA

Exton, PA
... Created Data Definition Documents (DDD) and converted xpt files for FDA submission. Created and maintained programs for tables, listings and final submissions of FDA submissions. Created new variables for AE data set for AEdur (Adverse Event ... - 2022 Dec 17

Wilmington, DE
... Completed all skills training to meet all stringent FDA handling standards. Effectively assisted manager on duty with daily closing routine completing daily closing reports. Quality Assurance Associate Hygiena Qualicon LLC – 2 Boulden Circle New ... - 2022 Oct 24

Exton, PA
... Output used in scheduled reviews by QA and Staff Engineers, and FDA auditors. Documents stored in Windchill indexed repository per FDA requirements. -Inaugurated and implemented use of local BASH Git, and remote BitBucket for version control and ... - 2022 Aug 24

Pottstown, PA
... Handled and forwarded any incoming FDA Drug Safety Reports to appropriate personnel in company in a timely manner; Retrieved and forwarded all study-related correspondence to our Records Management Department to be scanned, filed and archived; ... - 2022 Mar 12

Malvern, PA
... Areas of Knowledge Work Experience FDA regulations & GMP, OSHA rules and MSDS, Product R&D, Laboratory Testing, Q.C. & Equipment Validation, and strong background of instrumentation, USP, FCC, NF test methods. Jan 2022 – Current Innovative Pharma ... - 2022 Feb 02

Wilmington, DE
... (March 2016 – July 2018) MANUFACTURING INSPECTOR (Inspection Department) o Responsible for the inspection of different pharmaceutical products: Aranesp, Epogen, Neulasta, Repatha and others to attack cancer in coordination with FDA CFR’s policies. ... - 2021 Aug 20

Wilmington, DE
... Delaware Welcome Center, Newark, DE Food and Prep Service including ordering and receiving food product, managing inventory on FIFO schedule, preparing and serving foods while adhering to FDA guidelines. Responsible for training new staff and ... - 2021 Aug 20

Pottstown, PA
... monitor FDA website to identify DDMAC Warning Letters/Notices of Violation; prepare expense reports; compose correspondence; travel arrangements; reconcile corporate credit card accounts; conduct internet searches; compare contracts; prepare and ... - 2021 Jun 23

Chadds Ford Township, PA, 19317
... · Drug therapy reviews · FDA drug Safety guidelines. · Excel · Word · Microsoft · Typing · Phone · Compounding · Hospital · MTM · Access . Remote work capability Education: · Doctor of Pharmacy University of Sciences Philadelphia Bachelors of ... - 2021 Jun 06

Phoenixville, PA
... Ensure all validation activities and client deliverable meet FDA guidelines. Documented defects and track resolutions in Azure DevOps, ATP and Jira. Perform system/application testing for IRT/eCOA/Unified systems Comply with SOPs and ensure ... - 2021 May 24