Minneapolis, MN
... Certificate Summit Academy OIC Minneapolis, MN • Relevant Coursework: Medical and Pharmaceutical Terminology, Human Anatomy, FDA Drug Safety PROFESSIONAL EXPERIENCE Customer Service Representative May 2023 – Sep 2025 Express Employment Greater ...
- Jan 01
Hiram, GA, 30141
... • Audit readiness SQF, BRC, HACCP, INTERNAL, FDA, ARMY, GMP, PPE, CCP, SOP • Staff Interviews and reviews, created processes, and procedures. • Teambuilding through cross training and recognizing strengths and weaknesses. • Planning for success, ...
- 2025 Dec 31
Houston, TX
... Our team delivered working, validated systems and documentation to launch clinical trials that resulted in FDA approvals. Embedded Software Engineer/Architect: I developed embedded software for the FreeStyle glucose meter. 1997-1999 Software ...
- 2025 Dec 30
Bloomington, IN
... • Led and supported audits for FDA, BSI, and internal stakeholders, ensuring compliance with regulatory standards. • Spearheaded process improvement initiatives for CAPA management and change order procedures. Alkermes, Inc. Mar. 2020 – Jul. 2023 ...
- 2025 Dec 29
Breinigsville, PA
... The Learning Management module is validated according to the requirements of FDAs 21CFR Part 21 requirements and reduces FDA audit failure risk. Led the project team to select, design and implement cloud-based Employee and Manager Self-Serve and ...
- 2025 Dec 28
Trenton, NJ, 08611
... IND Annual Reports, PSURs, Risk Management Plans (RMPs), Investigator Brochures (IB), Company Core Safety Information (CCSI), and Company Core Data Sheets (CCDS) in compliance with ICH E2A–E2F, FDA 21 CFR, and EU pharmacovigilance legislation. ...
- 2025 Dec 26
Kingsport, TN
... C O N T A C T P R O F I L E Prescription data entry Inventory audits Excellence medication knowledge Software and computer proficiency Verifying and billing insurance Recording medical information Filling prescriptions HIPPA and FDA compliance DUR ...
- 2025 Dec 25
Rancho Cucamonga, CA
... SKILLS: • Calipers • Self-Motivate • Proficiency • Auditing • Task Prioritized • Organizational Skills • Blueprint Reading • Critical Thinking • FDA & OSHA Compliance • Manufacturing • GMP & ISO Compliance • Visual Inspection • Schematic Reading • ...
- 2025 Dec 24
Lithonia, GA
... • Assessed service events for complaints and safety incidents, ensuring FDA and ISO compliance. • Collaborated with Global Sales and Service to gather information for complaint investigations. • Generated quality data to identify product trends and ...
- 2025 Dec 24
Chicago, IL
... Guided the QA/RA team to comply with stringent quality, safety, and regulatory standards, including those set by FDA, ISO 13485, ISO 14001, ISO 18001, ISO 9001, and AS9100. Fostered a culture of quality and compliance through proactive leadership, ...
- 2025 Dec 24