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Quality Specialist, CAPA

1 month ago

Minneapolis, United States GForce Life Sciences Full time
Job DescriptionJob DescriptionClinical Quality Specialist, GCP, Medical Device/Pharmaceuticals 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 of 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

·        Main duty will be to support quality system implementation in a clinical research setting, focusing on Corrective and Preventive Action activities (CAPA).

·        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.

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

·        10+ years’ experience in CAPA-related work

Nice to Have

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

·        Medical device research experience preferred but not mandatory.

·        Exposure to clinical research audits and/or quality system familiarity is an asset.

Term & Start

·        5+ month contract

·        Start ASAP

·        Onsite Locations: Los Angeles, CA; Minneapolis, MN; Dallas, TX

·        Benefits included (Medical, Dental, Vision, 401k)

·        Full time (40hrs/week)

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