Quality Assurance Specialist II

The Quality Assurance (QA) Associate II supports and assists with supporting and driving the Quality and Compliance program within Broad Clinical Laboratories by contributing to the implementation, maintenance, and continuous improvement of the Quality Management System (QMS). This role requires a self-directed individual who can independently manage responsibilities, proactively identify gaps, and take initiative in advancing quality processes with moderate oversight.

This position helps ensure compliance with applicable regulatory and accreditation standards, including CLIA, CAP, CLEP, and ISO 9001, while promoting a culture of quality, safety, and continuous improvement.

The QA Associate partners with laboratory operations supporting next-generation sequencing (NGS), genotyping, and other data generation workflows to ensure adherence to established procedures, documentation practices, and regulatory requirements across pre-analytical, analytical, and post-analytical phases of testing.

Essential Functions:

Quality Management System (QMS) Support

• Supports and sustains compliance with the Broad Quality Management System (BQMS) through independent execution of assigned activities
• Initiates document control activities, including SOP formatting, version control and review cycles, ensuring timely progression without reliance on direct oversight.
• Ensures quality documentation is complete, accurate, and compliant with internal guidelines and regulatory requirements
• Participates in and proactively drives change management processes, including documentation updates and tracking
• Performs user acceptance testing and documentation for change management software

Quality Assurance & Compliance Activities

• Independently monitors quality assurance (QA) and quality control (QC) activities across laboratory operations
• Supports tracking and documentation of:
• Personnel records
• Competency assessments
• Equipment maintenance and calibration records
• Proficiency testing participation and performance
• Critically reviews quality records to ensure compliance with SOPs and regulatory standards, escalating risks and proposing solutions as needed

Regulatory & Accreditation Support

• Maintains working knowledge of CLIA, CAP, CLEP, and ISO 9001 requirements
• Proactively ensures laboratory practices align with applicable regulatory and accreditation standards
• Facilitates audit readiness by independently reviewing and validating requested documentation for technical accuracy and regulatory compliance prior to external submission.
• Evaluates key performance indicators (KPIs) and quality metrics, independently identifying trends and addressing compliance gaps ahead of inspections.

Quality Events (Deviations, Nonconformances, CAPA)

• Independently logs, tracks, and maintains records of deviations, nonconformances, and incidents
• Contributes to root cause analysis and corrective and preventive action (CAPA) documentation
• Takes ownership of assigned quality events, ensuring timely progression, follow-up, and closure of corrective actions.

Training & Competency

• Supports maintenance of training records and training matrices
• Assists in onboarding, retraining, and annual competency requirements
• Ensures training documentation meets regulatory and internal standards

Quality Metrics & Continuous Improvement

• Collects, analyzes, and trends quality metrics (e.g. error rates, compliance trends) with moderate supervision.
• Exercises independent judgment in prioritizing audit finding resolutions by identifying high risk areas that can be addressed by improvement activities.
• Leads or initiates continuous improvement efforts, including Lean or Six Sigma projects, from concept through implementation.

Qualifications Minimum Required Education & Experience:

• Bachelor's degree in Biology, Molecular Biology, Chemistry, Medical Technology, or related scientific discipline
• 2-4 years of experience in a clinical and/or research laboratory environment operating under a quality management syste,

Knowledge, Skills & Abilities:

• Knowledge of clinical laboratory regulatory requirements (CLIA, CAP, CLEP)
• Familiarity with quality systems (e.g., ISO 9001, GCLP, GMP) preferred
• Understanding of laboratory…