Clinical Quality Specialist
📋 Role Overview & Responsibilities
Clinical Quality Specialist, GCP, Medical Device/Pharmaceuticals SummaryOur client, a global medical device company, has engaged GForce Life Sciences to provide a Clinical Quality Specialist (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 RoleSupport 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 (review of reported protocol deviations, support clinical study support questions related to regulatory requirements and compliance).Potential to support procedure improvement opportunities & GCP training needs.
Mandatory RequirementsBachelor’s degree in scientific/engineering related field.2+ years’ experience supporting clinical quality activities/ensuring GCP compliance in GCP & FDA-regulated activities; medical devices research experience preferred but not mandatory.Exposure to clinical research audits and/or quality system familiarity is an asset.
Nice to HaveCertified clinical/quality auditor with ISO-1485 experience.
Term & Start3-6+ month contract with strong possibility of extensionStart ASAPOnsite Locations: Minneapolis, MN; Los Angeles, CA; Dallas, TXBenefits included (Medical, Dental, Vision, 401k)Full time (40hrs/week)Hourly rate: $35-45
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This position is located in Minneapolis, MN with potential relocation and sponsorship assistance depending on candidate qualifications.
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