Quality Assurance (QA) Associate II (Clinical Lab)

TL;DR

Quality Assurance (QA) Associate II (Clinical Lab): Supporting and driving the Quality and Compliance program within clinical laboratories with an accent on the implementation and continuous improvement of the Quality Management System. Focus on maintaining compliance with CLIA, CAP, and ISO 9001 standards across NGS and genotyping workflows.

Location: On-Site in Burlington, MA

Salary: $70,000 – $94,000 per year

Company

The hirify.global is a leading research organization focused on genomic and biomedical research to improve human health.

What you will do

• Sustain the Broad Quality Management System (BQMS) through independent document control, SOP formatting, and version control.
• Monitor QA/QC activities, including personnel records, competency assessments, and equipment calibration across laboratory operations.
• Ensure alignment with CLIA, CAP, CLEP, and ISO 9001 regulatory and accreditation standards.
• Manage quality events by logging and tracking deviations, nonconformances, and incidents, while contributing to root cause analysis and CAPA.
• Maintain training records and matrices, assisting with staff onboarding and annual competency requirements.
• Analyze quality metrics and lead continuous improvement efforts using Lean or Six Sigma methodologies.

Requirements

• Bachelor’s degree in Biology, Molecular Biology, Chemistry, Medical Technology, or a related scientific discipline.
• 2–4 years of experience in a clinical or research laboratory environment operating under a quality management system.
• Knowledge of clinical laboratory regulatory requirements including CLIA, CAP, and CLEP.
• Strong attention to detail and organizational skills for documentation and record review.
• Ability to work independently and manage priorities with moderate supervision.
• Effective written and verbal communication skills.

Nice to have

• Familiarity with ISO 9001, GCLP, or GMP quality systems.
• Experience with Laboratory Information Management Systems (LIMS).
• Knowledge of quality improvement methodologies such as Lean or Six Sigma.

Culture & Benefits

• Comprehensive benefits including medical, dental, vision, life, and disability insurance.
• 401(k) retirement plan, flexible spending, and health savings accounts.
• Generous time off: 13 paid holidays, winter closure, and paid time off.
• Parental and family care leave.
• Employee assistance program.