About the Company
Quest Diagnostics empowers people to take action to improve health outcomes. We are a leading provider of diagnostic information services, offering a broad range of innovative laboratory services that provide essential health information to patients and healthcare providers. With a nationwide network of patient service centers and laboratories, we are committed to excellence in testing, patient care, and scientific innovation.
Job Description
We are seeking a highly motivated and detail-oriented Laboratory Quality Coordinator with a strong regulatory focus to join our team in Omaha, NE. This role is crucial for maintaining the highest standards of quality and compliance within our laboratory operations. The successful candidate will be responsible for overseeing the implementation and maintenance of our Quality Management System, ensuring adherence to all relevant local, state, and federal regulations, as well as industry standards. This position requires a proactive individual who can effectively collaborate with various departments, conduct internal audits, manage documentation, and drive continuous improvement initiatives to uphold our commitment to diagnostic excellence and patient safety.
Key Responsibilities
- Develop, implement, and maintain the laboratory's Quality Management System (QMS) in accordance with CLIA, CAP, COLA, and other relevant regulatory requirements.
- Conduct regular internal audits and inspections to ensure compliance with quality standards and regulatory guidelines, identifying areas for improvement.
- Manage and maintain all quality control documentation, policies, and procedures, ensuring they are current, accurate, and accessible.
- Investigate and document non-conformances, deviations, and customer complaints, implementing corrective and preventive actions (CAPA) effectively.
- Coordinate and support external regulatory inspections and audits, serving as a primary point of contact.
- Provide training and guidance to laboratory staff on quality control procedures, regulatory compliance, and best practices.
- Monitor key quality indicators and prepare reports for management review, highlighting trends and recommending solutions.
- Facilitate continuous improvement initiatives, driving a culture of quality throughout the laboratory.
- Stay current with changes in regulatory requirements and industry standards, updating QMS processes as necessary.
Required Skills
- Bachelor's degree in Medical Technology, Clinical Laboratory Science, or a related scientific field.
- Minimum of 3 years of experience in a clinical laboratory setting with a focus on quality assurance or regulatory compliance.
- In-depth knowledge of CLIA, CAP, COLA, and other relevant laboratory accreditation and regulatory standards.
- Proven experience with Quality Management Systems (QMS) and CAPA processes.
- Strong analytical skills with the ability to interpret complex data and identify trends.
- Excellent written and verbal communication skills, capable of effectively interacting with all levels of staff and external auditors.
- Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint).
Preferred Qualifications
- ASCP certification (MT/MLS).
- Experience with laboratory information systems (LIS).
- Certified Quality Auditor (CQA) or similar quality certification.
- Experience in training and developing quality programs.
Perks & Benefits
- Competitive salary and performance bonuses.
- Comprehensive health, dental, and vision insurance plans.
- Generous paid time off (PTO) and holidays.
- 401k Matching program to help you plan for your future.
- Tuition reimbursement and professional development opportunities.
- Life and disability insurance.
- Employee assistance programs.
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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