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documentation quality assurance audits sops clia📋 Description
- Develop and maintain SOPs and work instructions through document lifecycle management
- Review change status activities to ensure compliance with configuration management
- Train and support lab staff on QA processes and procedures
- Maintain quality records for facility, safety, equipment lifecycle, personnel, processing, QC
- Develop QA programs to ensure CLIA, CAP, NYSDOH compliance and best practices
- Prepare for external audits by CLIA, CAP, NY, and regulators
🎯 Requirements
- Bachelor of Science in Medical Technology, Biology, Chemistry, or related field
- Minimum 1 year in a high-complexity CLIA, CAP, or NYS laboratory
- Knowledge of regulatory requirements and quality management principles
- High initiative and self-motivation
- Excellent communication and cross-functional collaboration
- Detail-oriented with analytical and problem-solving skills
🎁 Benefits
- Rockstar team environment
- Open culture with weekly Town Hall meetings
- Impact lives of hundreds of thousands of patients
- Medical benefits with premium coverage on select plans
- Generous family leave (16 weeks, 100%)
- 4% company match retirement plan
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