Clinical Quality Specialist GCP

3 days ago


Reston, Virginia, United States GForce Life Sciences Full time

Clinical Quality Specialist, GCP, Medical Device/Pharmaceuticals

About the Role

GForce Life Sciences is seeking a Clinical Quality Specialist to support our client, a global medical device company, in ensuring compliance with GCP guidelines and international and national standards, regulations, and guidelines.

Key Responsibilities

  • Support general audit administration, including tracking and following up on audit deliverables.
  • Support inspection readiness activities through quality checks and document reviews.
  • Provide general clinical study compliance-related support, including sponsor oversight and compliance-related questions.
  • Support procedure improvement opportunities and GCP training needs.
  • Support quality system implementation in clinical research settings, including Corrective and Preventive Action activities (CAPA).

Requirements

  • Bachelor's degree in a scientific or engineering-related field.
  • Experience supporting clinical quality activities and ensuring GCP compliance in GCP and FDA-regulated activities.
  • Medical devices research experience is preferred but not mandatory.
  • Exposure to clinical research audits and/or quality system familiarity is an asset.

Preferred Qualifications

  • Certified clinical/quality auditor with ISO-13485 experience.

Work Arrangements

Contract through the end of the year, with a strong possibility of extension. Hybrid locations: Maple Grove, MN; Los Angeles, CA; Dallas, TX. Benefits included (Medical, Dental, Vision, 401k). Full-time (40 hours/week).



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