Quality Assurance Specialist
$75,000–$85,000 year
On-site · Boulder, Colorado, United States
Job Summary
Quality Assurance Specialist embedded in the Quality Management System supporting investigations, documentation, audits, and cross-functional processes in a regulated clinical environment. Key responsibilities include managing NCR/CAPA investigations from root cause to corrective actions, handling document management in the eQMS with change-control activities, providing QA support to Laboratory Operations, overseeing document control and training programs, contributing to Change Management activities, conducting internal audits for QMS compliance, developing and revising SOPs to meet regulatory requirements, evaluating tools and methods to improve process efficiency, identifying quality test methods and risk assessments for new products, and supporting supplier approval and laboratory quality compliance processes.
Required Qualifications
- Bachelor’s degree in life sciences, engineering, or a related technical field
- 5+ years of Quality Assurance experience in a regulated environment (clinical laboratory, diagnostics, medical device, or pharmaceutical)
- Solid knowledge of ISO 13485, 21 CFR 820, and CAP/CLIA clinical regulations
- Hands-on experience with NCR/CAPA investigations, internal audits, document control, SOP development, and risk management
- Strong communication skills (verbal and written)
- Ability to manage multiple priorities in a fast-moving, cross-functional environment
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