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    Clinical Quality Specialist - Minneapolis, United States - GForce Life Sciences

    GForce Life Sciences
    GForce Life Sciences Minneapolis, United States

    3 weeks ago

    GForce Life Sciences background
    Description
    Summary
    Our 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 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 (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 Requirements
    • Bachelor'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 Have
    • Certified clinical/quality auditor with ISO-1485 experience.
    Term & Start
    • 3-6+ month contract with strong possibility of extension
    • Start ASAP
    • Onsite Locations: Maple Grove, MN; Sylmar, CA; Palo Alto, TX
    • Benefits included (Medical, Dental, Vision, 401k)
    • Full time (40hrs/week)
    • Hourly rate: $35-45
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