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Clinical Quality Consultant

1 month ago

Los Angeles, United States GForce Life Sciences Full time
Job DescriptionJob DescriptionSummary

Our client, a global medical device company, has engaged GForce Life Sciences to provide a Clinical Quality Consultant (GCP). This position will report to the Associate Director, Clinical Quality. This individual will provide support and promote collaboration to ensure all systems, processes and their outcomes are compliant with GCP guidelines, and applicable international and national standards, regulations, and guidelines.

Duties / Expectations of Role
  • Support general audit administration (tracking & following up audit deliverables).
  • Support inspection readiness activities via quality check and document review activities.
  • Provide general clinical study compliance-related support (sponsor oversight activity; compliance-related questions)
  • Support procedure improvement opportunities & GCP training needs.
  • Support quality system implementation in clinical research setting, including Corrective and Preventive Action activities (CAPA)
Mandatory Requirements
  • Bachelor’s degree in a scientific/engineering-related field.
  • 10+ years’ experience supporting clinical quality activities/ensuring GCP compliance in GCP & FDA-regulated activities
  • Medical devices experience
  •  Exposure to clinical research audits and/or quality system familiarity is an asset.
Nice to Have
  • Certified clinical/quality auditor with ISO-13485 experience.

Term & Start

  • Contract through mid-December
  • Start ASAP
  • Onsite Locations: Maple Grove, MN; Sylmar, CA; Plano, TX
  • Benefits included (Medical, Dental, Vision, 401k)
  • Full time (40hrs/week)

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