Quality Assurance Specialist

The Quality Assurance Specialist supports the Quality Assurance Manager in implementing and maintaining laboratory quality systems, compliance, and regulatory oversight. This role is responsible for coordinating, executing, and assessing quality initiatives related to all phases of patient testing—pre-analytical, analytical, and post-analytical. The Specialist ensures regulatory compliance with CLIA, The Joint Commission, and other applicable accrediting bodies; maintains laboratory licensure; manages quality improvement and proficiency testing programs; leads internal audits; and supports continuing education initiatives. Additionally, this role provides operational support by serving as Testing Personnel on an as-needed basis.

• Regulatory & Compliance Oversight
  • Ensure laboratory operations comply with CLIA, The Joint Commission, and all applicable state and federal regulations.
  • Maintain current laboratory licenses and registrations; oversee timely submission of renewals and updates.
  • Coordinate and prepare for inspections and audits from accrediting and regulatory agencies; manage documentation and follow-up for findings.
  • Serve as a regulatory resource to lab leadership and cross-functional teams.
• Quality Management Systems
  • Oversee and evaluate quality control processes across the full testing lifecycle.
  • Conduct internal audits to assess compliance and recommend opportunities for process improvement.
  • Track and report key quality indicators and use data insights to drive continuous improvement.
  • Assist in developing and maintaining laboratory Quality Assurance (QA) and
  • Continuous Quality Improvement (CQI) plans.
  • Compile and submit the annual QA report to leadership.
  • Maintain document control processes using tools such as MediaLab, ensuring timely review and version control.
• Policy and Procedure Development
  • Draft, revise, and implement laboratory SOPs, policies, and forms aligned with operational needs and compliance standards.
  • Manage document workflows for review, approval, and version tracking.
  • Conduct training and communication for new and revised policies to ensure staff awareness and adherence.
• Proficiency Testing and Corrective Action
  • Coordinate proficiency testing (PT) activities including enrollment, scheduling, testing execution, and result submission.
  • Investigate and document any unsatisfactory PT results or deviations; implement and track corrective and preventive actions (CAPA).
  • Maintain organized PT records for compliance and inspection readiness.
• Training, Competency & Safety
  • Support development and tracking of training programs and competency assessments across laboratory roles.
  • Monitor and enforce laboratory safety protocols in accordance with OSHA, CLIA, and local regulations.
  • Support departmental continuing education to maintain staff preparedness, promote professional development, and uphold regulatory compliance.
• Operational Support
  • Serve as Testing Personnel on an as-needed basis to maintain testing continuity during staff absences, high-volume periods, or emergency coverage needs

• EXPERIENCE
• • Minimum of two (2) years of relevant experience in a clinical laboratory, including experience with QA programs, audits, and compliance.
  • Experience coordinating proficiency testing and managing CAPA processes is highly desirable.
  • Familiarity with MediaLab, Laboratory Information Systems, and CareLogic preferred
  • Proficiency with Microsoft Office Suite (Excel, Word, Access).
  • Strong analytical, organizational, and problem-solving abilities.
  • Clear verbal and written communication skills.
  • Ability to work independently and collaboratively across functional teams to drive process improvements.

• EDUCATION:
• • Required: Bachelor’s degree in a relevant scientific or healthcare discipline from an accredited institution.
  • Preferred: Master’s degree in a related field.
  • Required: Must meet CLIA qualifications for Testing Personnel in a high-complexity laboratory.
  • Preferred: CLIA-qualified General Supervisor designation.

BENEFITS AND PERKS: 

• PTO (Paid Time Off) 
• Immediately vested and eligible in 401k program with employer match.  
• Company sponsored ongoing training and certification opportunities. 
• Full comprehensive benefits package including medical, dental, vision, short term disability, long term disability and accident insurance. 
• Tuition Reimbursement after 1 year in related field  
  
  

We offer competitive compensation, comprehensive benefits, and a supportive work environment dedicated to your professional growth and development. 

Ready to shape our future by bringing in top talent? Apply now and be a key player in our success!