Quality Assurance Specialist
Labcorp is a global leader in laboratory services, providing insights and answers that help healthcare providers, patients, researchers, pharmaceutical companies, and health systems make confident decisions and improve outcomes. Through unparalleled science, data, technology, and a laboratory network, we advance diagnostics, accelerate innovation, and address critical health challenges. By leveraging advanced technologies, intelligent digital solutions, and data-driven innovation, we enhance operations and deliver greater value to customers and patients. With global scale and deep expertise, you’ll have the opportunity to do meaningful work, grow your career, and make a real impact on people’s health worldwide.
Responsibilities
- Supports supervisors with the review of quality control data to identify trends, problems, and accuracy issues.
- Examines outlier results and QA exception reports thoroughly and within required timeframes.
- Maintains complete, accurate, and up-to-date records (logs, reports, worksheets, paperwork) for immediate access or timely retrieval.
- Creates and updates QA procedures and documentation that are clear, accurate, and user-friendly.
- Assists in process improvement and quality improvement initiatives; supports QA plan reviews and report generation.
- Performs clerical and technical tasks such as data entry, report generation, communications, database maintenance, and filing.
- Participates in Lean activities (e.g., 5S) and ensures adherence to preventive maintenance and calibration schedules for equipment.
- Conducts high-complexity technical and non-technical testing per SOPs and protocols.
- Supports change control projects and assists with validations.
- Completes quality events in the Document Control system.
- Ensures compliance with CAP, CLIA, ISO, and other applicable regulations; supports audits and inspections.
- Manages training and competency programs for staff.
- Tracks, monitors, and presents operational and quality metrics to management.
- Initiates or supports corrective actions from audit observations and investigations; monitors effectiveness.
- Schedules and performs audits.
- Maintains documentation for regulated studies in compliance with applicable regulations.
- Oversees the proficiency testing program and ensures PT responses are submitted timely, processes PT evaluation, and facilitates PT failure investigation.
Requirements
- Bachelor’s degree in a Chemical or Biological science, Clinical Laboratory Science, or Medical Technology.
- 2 years or more of previous experience as a Medical Technologist or in a quality-related position.
Preferred Qualifications
- Current or prior Labcorp experience.
Skills
- General knowledge of laboratory regulations (CAP/CLIA/ISO) and licensing requirements.
- Basic understanding of audit-related requirements and procedures.
- Working knowledge of quality assurance best practices and procedures.
- Excellent analytical, critical thinking, and problem-solving skills.
- Strong communication skills, both written and verbal.
- High level of attention to detail with strong organizational skills.
- Ability to work independently and within a team environment.
- Strong computer skills with proficiency in MS Office programs.
Schedule
Monday-Friday 8am-5pm
Benefits
- Medical, Dental, Vision, Life, STD/LTD.
- 401(k) with company match.
- Paid Time Off (PTO) or Flexible Time Off (FTO).
- Tuition Reimbursement.
- Employee Stock Purchase Plan.
Employees regularly scheduled to work 20 or more hours per week are eligible for comprehensive benefits. Employees scheduled for less than 20 hours, Casual, Intern, and Temporary employees are eligible for the 401(k) Plan only. Employees on a 7-on/7-off schedule receive all benefits except PTO or FTO.