FDA Resumes

East Brunswick, NJ, 08816
... • Prepared and submitted over 30 regulatory submissions, including FDA 510(k) applications for Class I and II medical devices, ensuring compliance with 21 CFR Part 820 regulations. • Authored, reviewed, and approved Product Quality Complaint (PQC) ... - Feb 05

Laurel, MD
... Food and Drug Administration (FDA) Silver Spring, MD August 2015– November 2018 Office Automation Clerk Used Microsoft Word to compose and edit standard documents, correspondence and emails for the Director, Program Management Office (PMO), Center ... - Feb 05

White Oak, PA, 15131
... ●Provided training programs, staff educational in-services, safety leadership, health, environmental, including compliance and regulatory issues (i.e., FDA, OSHA, EPA) and updates to current and new employees. Additional Relevant Experience Sunoco ... - Feb 04

Centreville, VA
... EXPERIENCE Oct 2017-JAN 2023 DRUG SAFETY SPECIALIST HealthCore [previously New England Research Institutes]-Watertown, MA Responsible for the review, evaluation and management of adverse event reports in accordance with FDA, EMEA, other applicable ... - Feb 04

Danbury, CT
... Participated in the setup of Shift Rules and Work Area assignments, addressing 24x7 manufacturing shift coverage and FDA audit compliance. Worked closely with HR and Operations to define Scheduling eligibility rules for lab technicians and clinical ... - Feb 04

San Pedro, CA
... Responsible for contacting and alerting pharmacies and consumers to DEA and FDA drug recalls. *Promoted from Executive Assistant. 6/88-7/90 LOGICON, INC. “ADMINISTRATIVE ASSISTANT” Prepared and compiled cost proposals and government contracts for ... - Feb 04

Eastman, GA
... planning (10+ years) • Trimming (cutting method) • Technical support • APIs • Help desk • Public speaking • Event sales • FDA regulations • Microsoft Word (9 years) • Sheet metal stamping • Materials handling • Custodial experience • Patient ... - Feb 04

Oceanside, CA
... to $240 MM High Mix, High/Low Volume 5S, VSM, Kaizen, SMED 1000+ Employees Operations Global Multi-Site Management MRP and ERP Systems ISO 9001:2015, AS9100 Poka Yoke, TPM, 6-Sigma FDA, 510K, GMP, Validation Medical Devices Manufacturing Electronics ... - Feb 04

Covington, GA
... ingredients, and finished goods to support production schedules and fulfillment goals ● Ensure full compliance with GMP, OSHA, FDA, TTB, sanitation, pest control, insurance, and fire code regulations, protecting both operational integrity and ... - Feb 03

Bridgewater, NJ
... all within the guidelines as established by GMP’s, FDA and ISO regulations. • Developed partnerships with all suppliers emphasizing ones that are sole sourced; achieved through routine site visits and audits. • Dispositioned all ECN’s, NCMR’s and ... - Feb 03