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: 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 workflows, including pre-analytical, analytical, and post-analytical phases Strong attention to detail and organizational skills, particularly in documentation and record review Effective written and verbal communication skills Ability to analyze data, identify trends, and independently drive problem-solving efforts Ability to work collaboratively in a cross-functional team environment Demonstrated ability to work independently, manage own priorities, and execute tasks with moderate supervision Proactive, self-starter mindset with strong sense of ownership and accountability Ability to take initiative, follow through on commitment, and drive tasks to completion. Familiarity with document control and configuration management principles Experience with or ability to learn Laboratory Information Management Systems (LIMS) Willingness to learn and apply quality improvement methodologies (e.g., Lean, Six Sigma) The expected base pay range for this position as listed above is based on a 40 hour per week schedule. Broad provides pay ranges representing its reasonable and good faith estimate of what the organization reasonably expects to pay for a position at the time of posting. Actual compensation will vary based on factors including but not limited to, relevant skills, experience, education, qualifications, and other factors permissible by law. At Broad, your base pay is just one part of a comprehensive total rewards package. From day one, this role offers a competitive benefits package including medical, dental, vision, life, and disability insurance; a 401(k) retirement plan; flexible spending and health savings accounts; at least 13 paid holidays; winter closure; paid time off; parental and family care leave; and an employee assistance program, among other Broad benefits. The Broad Institute is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, national origin, religion, age, color, sex, disability, protected veteran status, or any other characteristic protected by local, state, or federal laws, rules, or regulations. Should you need a reasonable accommodation to complete the application or interview process, please contact View email address on click.appcast.io for assistance. #J-18808-Ljbffr Broad Institute