Sr. Clinical Quality Associate
$78,000–$156,000 year
On-siteMaple Grove, Minnesota, United States
Job Summary
Review study documents for compliance with medical device and GCP regulations, standards, and internal procedures. Act as a resource to clinical study teams regarding regulatory adherence and support compliant execution of clinical research projects. Generate CAPA documentation, including investigations, resolution plans, and implementation reports. Serve as a key player in preparing for and supporting internal and external audits, responding to findings through the CAPA process. Work cross-functionally to develop pragmatic, compliant solutions for CAPA activities and drive continuous process improvement. This role is based in Maple Grove, MN or Plano, TX, with a standard work shift.
Required Qualifications
- Bachelors Degree (± 16 years), In related field OR an equivalent combination of education and work experience
- Minimum 4 years, Related work experience with a solid understanding of specified functional area
- Broad knowledge and application of business concepts, procedures and practices
- Strong understanding of Good Clinical Practice (GCP) including U.S. regulations and international standards, Quality Assurance/Control, as well as of relevant regulations and procedures
- Strong written communication skills
- team player with autonomy capable of working independently under minimal supervision
- Planning and organizational skills
- Problem solving
- Adaptability
- Initiative / Innovation
- Independent decision making
- Yes, 5 % of the Time
Desired Qualifications
- Preferably has prior experience with GCP regulations and standards, including 21 CFR Parts 50, 54, 56, 812 and ISO 14155
- Prefer at least 5 years of medical devices, clinical research experience, or related industry
- Prefer at least 3 years of related work experience in Quality role in medical device area and/or clinical trial environment
- Prefer GCP audit experience
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