Lab QA Coordinator
$55,000–$55,000 year
On-siteFairfield, Ohio, United States
Job Summary
Coordinate day-to-day operation and maintenance of the laboratory Quality Management System (QMS) using MediaLab and related platforms. Manage document control processes, including creation, review, approval routing, and archival of standard operating procedures and quality records. Monitor training assignments and completion, support internal audits and accreditation activities, and track nonconformances to drive corrective and preventive actions. Collect, analyze, and report laboratory quality metrics while assisting with root cause analyses and continuous improvement initiatives. Facilitate quality meetings and prepare reports for management review to ensure adherence to CLIA, CAP, AABB, and ISO standards. Collaborate with laboratory operations and cross-functional teams to streamline workflows and strengthen quality processes.
Required Qualifications
- Bachelor's degree in Biology, Business Management, or a related field
- Minimum of 2 years of experience in quality assurance, quality control, laboratory operations, or a regulated healthcare/life sciences environment
- Experience supporting laboratory quality systems, audits, accreditation, or regulatory compliance activities
- Ability to sit, stand, and walk for extended periods
- Frequent use of computers and standard office equipment
- Ability to communicate effectively in person, by telephone, and electronically
- Occasionally required to lift up to 25 pounds
- Must comply with applicable laboratory safety requirements and PPE protocols
Desired Qualifications
- Experience using MediaLab, MasterControl, TrackWise, Qualtrax, or similar quality management systems
- Knowledge of laboratory accreditation and regulatory requirements such as CLIA, CAP, AABB, ISO, NATA, or similar standards
- Strong organizational skills and attention to detail with the ability to manage multiple priorities simultaneously
- Demonstrated analytical and problem-solving abilities
- Strong written and verbal communication skills
- Ability to analyze data and identify trends, risks, and opportunities for improvement
- Proficiency with Microsoft Office applications, including Excel, Word, and PowerPoint
- Ability to build collaborative working relationships across departments
- Self-motivated with the ability to work independently while contributing effectively within a team environment
- Strong judgment, professionalism, and discretion when handling sensitive information
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