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Clinical QA (GCP) Consultant
- Contract
- Good Clinical Practice (GCP)
- United States
Clinical QA (GCP) Consultant - Contract - Remote US
Are you ready to make a groundbreaking impact in the world of biotechnology? Join a growing company that's shaping the future of healthcare and science.
Proclinical is currently seeking a Clinical QA (GCP) Consultant to support global Clinical QA activities on a part-time basis. The position is remote, but there is a strong preference for a candidate based in New Jersey to occasionally visit the office. This is a part-time role, anticipated 24 hours per week, with flexibility in duration (approximately 4-5 months).
Primary Responsibilities:
- Management of GCP Quality Issues
- Provide input on CAPAs required for GCP
- Schedule, execute and report GCP audits including sites, vendors and GCP electronic systems
- Write/Revise and maintain Clinical Quality Assurance SOPs and Work Instructions, as directed
Skills & Requirements:
- Bachelor's degree in life sciences or a related field (advanced degree preferred).
- Minimum of 5+ years's experience in GCP Quality Assurance within the pharmaceutical, biotech, or CRO industry.
- Proficiency in conducting GCP audits (sites, vendors, systems).
- Strong knowledge of global regulatory requirements (e.g., FDA, EMA, MHRA).
If you are having difficulty in applying or if you have any questions, please contact Josh Godden at j.godden@proclinical.com
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