Quality Assurance Coordinator

Essential Duties & Responsibilities

• Cook up day-to-day operation and maintenance of the laboratory Quality Management System (QMS).
• Serve as a primary administrator and subject matter resource for MediaLab and related quality management platforms.
• Manage document control processes, including creation, review, approval routing, revision tracking, and archival of standard operating procedures (SOPs), forms, and quality records.
• Monitor training assignments and completion within MediaLab, partnering with leaders to ensure compliance with training requirements.
• Support internal audits, inspections, and accreditation activities, including preparation of documentation, records, and follow-up actions.
• Track, investigate, and document nonconformances, deviations, incidents, customer complaints, and quality events.
• Cook up corrective and preventive action (CAPA) activities and ensure timely completion of assigned actions.
• Aid in root cause analyses and continuous improvement initiatives designed to improve quality, efficiency, and compliance.
• Collect, analyze, trend, and report laboratory quality metrics and key performance indicators.
• Support quality-related regulatory compliance activities associated with CLIA, CAP, AABB, ISO, NATA, or other applicable laboratory standards.
• Aid in vendor quality documentation reviews and supplier qualification activities as assigned.
• Cook up quality meetings, maintain quality records, and prepare reports for management review.
• Aid in developing and delivering quality-related training and educational materials.
• Cook up collaboration with laboratory operations, technical staff, and cross-functional teams to ensure adherence to established quality standards.
• Support laboratory readiness for audits and inspections through ongoing monitoring and process reviews.
• Identify opportunities to streamline workflows and strengthen quality processes.
• Other duties as assigned or become evident.

Qualifications

• Bachelor's degree in Biology, Business Management, or a related field required.
• 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 required.
• Experience using MediaLab, MasterControl, TrackWise, Qualtrax, or similar quality management systems preferred.
• Working knowledge of quality systems and quality assurance principles within a laboratory, healthcare, diagnostic, manufacturing, or regulated environment.
• Familiarity with document control, CAPA, audit management, training compliance, and continuous improvement processes.
• Knowledge of laboratory accreditation and regulatory requirements such as CLIA, CAP, AABB, ISO, NATA, or similar standards preferred.
• 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.
• The ability to analyze data and identify trends, risks, and opportunities for improvement.
• Proficiency with Microsoft Office applications, including Excel, Word, and PowerPoint.
• The 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.