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Technical Writer Customer Service

San Francisco, CA, 94114
... • ISO 9000 compliant, compliant to FDA and GMP documents and Auditor skills. • Corrective Action follow-up and Continuous Improvement Techniques/Protocol. • Trilingual - English, Portuguese, and Spanish. • Interpreter for Portuguese to English ... - Jun 20

On-Site Engineering Coordinator

Fremont, CA
... 7)Familiarity with cGMP, FDA OSHA and required regulatory requirements. 8) Update maintenance-related data of the instruments and works performed in the CMMS software. Experienced with Microsoft excel, Smart sheet and VLOOKUP. 9)Understands SOPs, ... - Jun 20

Clinical Research Data Entry

Richmond, TX, 77407
... Complying with ICH GCP guidelines, FDA regulations and company SOPs. IQVIA: Clinical Research Coordinator (October 2020- February 2022) Data Collection, Query Resolution, obtaining Informed Consent, filling Case Report Forms. Data entry into ... - Jun 20

Information Technology Technical Support

Springfield, PA, 19064
... Science, Engineering, Technology & Telecom Services) – West Chester, PA 10/2021 – 09/2023 Provided oversight of vendor documented changes to ensure FDA regulatory compliance for Johnson & Johnson/Ethicon/US Hospital MedTech family of companies. ... - Jun 20

Clinical Research Public Health

Terrell, TX
... Redbock- AstraZeneca/Alexion Pharmaceutical Boston, MA Jan 2020-2022 Lead Epidemiologist/Scientist (24Months Contract) Subject matter expert on clinical trial diversity and optimization to meet FDA requirements. Customized rare disease clinical ... - Jun 20

Regulatory Affairs Project Management

Lansdale, PA
... records and process-related documentation (process maps, job aids, project trackers, checklists) ●Comprehensive knowledge of FDA drug regulations and GCP/GCLP regulations ●Tracked compliance issues in Quality Management System (QMS), policies, and ... - Jun 20

Senior Clinical Research Associate

Staten Island, NY
... Skilled in fostering strong site relationships, leading monitoring activities, and ensuring adherence to FDA and ICH/GCP guidelines. Proficient with clinical trial systems including CTMS, EDC, eTMF, and IRT. Therapeutic Areas Oncology- Solid Tumor, ... - Jun 20

Operations Manager Quality Control

Houston, TX
... ● Ensured compliance with FDA and international medical regulations. Environment Control Company – USA Operations Manager / Supervisor 08/2012 – 11/2023 ● Promoted from Lead Controller Supervisor Operations Manager, overseeing facility maintenance, ... - Jun 20

Quality Assurance Food Safety

Chicago, IL
... Directly interfaced with regulatory representatives (FDA, USDA, BRC, SQF & Customer Audit personnel) Proven track record of Excellent troubleshooting and problem-solving abilities. Excellent team player. Works well with direct reports, management, ... - Jun 19

Senior Product Manager

San Diego, CA
... Mapped regulatory pathway for FDA Class I software device; collaborated with advisors on risk classification and clinical workflow alignment. Built prototype and secured pre-seed funding; product development paused due to COVID-related market ... - Jun 19
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