About the Company
Quest Diagnostics is the world’s leading provider of diagnostic information services. We provide insights that help people live healthier lives, offering a broad portfolio of innovative laboratory services that enable diagnosis and treatment of a wide range of diseases and conditions. With a presence across the globe, we are committed to quality, innovation, and patient care.
Job Description
We are seeking a dedicated and meticulous Laboratory Quality Coordinator with a strong regulatory focus to join our team in Austin, TX. This pivotal role ensures the laboratory maintains the highest standards of quality and compliance with all applicable local, state, and federal regulations, including CLIA, CAP, and FDA guidelines. The ideal candidate will be instrumental in developing, implementing, and maintaining our quality management system, conducting internal audits, and preparing for external inspections. This position offers excellent growth opportunities and includes robust benefits, such as 401k matching.
Key Responsibilities
- Develop, implement, and maintain the laboratory's Quality Management System (QMS) in accordance with CLIA, CAP, FDA, and other relevant regulatory requirements.
- Conduct regular internal audits and inspections to ensure compliance with quality standards and regulatory guidelines.
- Manage and investigate non-conformances, deviations, and corrective/preventative actions (CAPA), ensuring timely resolution and effectiveness checks.
- Prepare and manage all necessary documentation for regulatory inspections and accreditation processes.
- Provide training to laboratory staff on quality procedures, regulatory updates, and best practices.
- Monitor and analyze quality metrics and trends to identify areas for improvement and implement continuous quality enhancement initiatives.
- Collaborate with laboratory management and staff to foster a culture of quality and continuous improvement.
- Stay current with regulatory changes and update QMS policies and procedures accordingly.
Required Skills
- Proven experience in laboratory quality assurance and regulatory affairs.
- In-depth knowledge of CLIA, CAP, FDA, and other relevant laboratory accreditation standards.
- Experience with Quality Management Systems (QMS) and CAPA processes.
- Strong auditing and analytical skills.
- Excellent written and verbal communication abilities.
- Detail-oriented with strong organizational and problem-solving skills.
- Proficiency in Microsoft Office Suite.
Preferred Qualifications
- Bachelor's degree in Medical Technology, Clinical Laboratory Science, or a related scientific field.
- ASQ Certified Quality Auditor (CQA) or Certified Quality Manager (CQM) certification.
- Experience with Laboratory Information Management Systems (LIMS).
- 3+ years of experience in a regulated laboratory environment.
Perks & Benefits
- Competitive annual salary
- Comprehensive health, dental, and vision insurance
- 401k matching program
- Generous paid time off (PTO)
- Professional development and continuing education opportunities
- Life and disability insurance
- Employee assistance program
How to Apply
If you are interested in this position, please click the "Apply Now" button below. To ensure your application is properly considered, please prepare the following:
- An up-to-date Resume or CV
- A brief cover letter summarizing your experience and motivation
Applications are reviewed on a rolling basis. Only shortlisted candidates will be contacted for an interview.
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