Quality Assurance Specialist II
$70,000–$94,000 year
On-site · Burlington, Massachusetts, United States
Job Summary
Quality Assurance Specialist II to support Broad Clinical Laboratories' Quality Management System (QMS) and regulatory compliance (CLIA, CAP, CLEP, ISO 9001). Responsibilities include independent execution of QA/QC activities, document control, change management, training and competency, data analysis of KPIs and quality metrics, CAPA handling, audit readiness, and continuous improvement (Lean/Six Sigma). The role partners with laboratory operations supporting NGS, genotyping, and data generation workflows across pre-analytical, analytical, and post-analytical phases, ensuring procedural adherence and regulatory compliance. Requires a bachelor’s degree in a related scientific discipline and 2–4 years in a clinical/research lab with quality management system experience; strong documentation, communication, and independent-working capabilities. Base pay is 70,000–94,000 USD annually, with comprehensive benefits.
Required Qualifications
- 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 system
- 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)
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