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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
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
Coventry, RI
... support manufacturing when there are potential schedule changes Ensure any expiring material is disposed of in accordance with FDA guidelines SOP document author/owner utilizing CDOCs Special Projects: Worked with internal departments and an outside ...
- Feb 03
Waukesha, WI
... to develop innovative content strategies Final content review will align with Branding, Trademark, Registration and FDA requirements as well as Advertising and Promotional material review Directly contribute to $80M sales goal for GE service ...
- Feb 03
Reisterstown, MD
... Pharmaceutical & Tobacco Product Regulation (FDA CTP & CDER) ● Conducted expert analysis and strategic test plans for complex regulatory workflows, simplifying access to crucial information. ● Led design and front-end development (HTML/CSS) of ...
- Feb 03
Clarksburg, MD
... Adept at leading teams, maintaining compliance with HIPAA and FDA standards, and improving workflow efficiency. Demonstrated expertise in patient care, technical documentation, redaction, and quality assurance. Recognized for reliability, attention to ...
- Feb 02