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hipaa clia cap gclp iso-20916📋 Description
- Support internal and external audits (GCP sponsor, CLIA/CAP, ISO 13485)
- Collect and trend quality metrics for clinical trials.
- Oversee CAPAs, deviations, and NCRs for clinical trials.
- Write/revise procedures and forms; assist with training.
- Perform statistical analysis and hypothesis testing (AQLs).
- Support compliance to CLIA, FDA QMSR, ISO 13485, HIPAA.
🎯 Requirements
- BS or equivalent in science, engineering or related field
- 2-3 years QA in biotech/medical device preferred
- Audit experience (internal, third-party and regulatory)
- ASQ certifications preferred
- Knowledge of GCLP, ICH-E6, ISO 20916, CLIA/CAP and ISO 13485
- Computer skills: MS Word, Excel, PowerPoint
- Strong technical writing and communication
🎁 Benefits
- Competitive benefits: medical, dental, vision, life, disability
- Fertility care benefits and free testing for employees and families
- Pregnancy/baby bonding leave, 401k benefits, commuter benefits
- Generous employee referral program
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