About the Company
LabCorp (Laboratory Corporation of America Holdings) is a leading global life sciences company that provides comprehensive clinical laboratory and end-to-end drug development services. With a mission to improve health and improve lives, LabCorp delivers world-class diagnostic solutions, bringing innovative and pioneering insights to patient care, and supporting the development of life-changing therapies. Our commitment to quality, compliance, and scientific excellence is at the heart of everything we do.
Job Description
LabCorp is seeking a highly motivated and detail-oriented Laboratory Compliance Officer with a strong focus on Quality Assurance (QA) and Quality Control (QC) to join our team. This is a 100% remote position, offering flexibility and the opportunity to contribute significantly to our commitment to regulatory adherence and operational excellence from anywhere. The successful candidate will be instrumental in ensuring all laboratory operations comply with relevant national and international regulations, standards, and internal policies, directly impacting the integrity and reliability of our diagnostic and research services. You will play a critical role in maintaining our high standards of quality through robust QA/QC oversight and continuous improvement initiatives.
Key Responsibilities
- Develop, implement, and maintain comprehensive quality management systems (QMS) in accordance with CLIA, CAP, FDA, ISO, and other applicable regulatory standards.
- Conduct internal and external audits to assess compliance with regulatory requirements, quality standards, and company policies, identifying areas for improvement.
- Oversee and manage the Quality Control (QC) program, including review of QC data, troubleshooting QC issues, and ensuring appropriate corrective actions are taken.
- Investigate and document deviations, non-conformances, and CAPA (Corrective and Preventive Actions) processes, ensuring effective resolution and prevention of recurrence.
- Provide expert guidance and training to laboratory staff on compliance matters, quality procedures, and regulatory updates.
- Prepare and submit regulatory reports and documentation as required by various agencies.
- Stay abreast of changes in regulatory requirements and industry best practices, implementing necessary updates to internal policies and procedures.
- Collaborate with cross-functional teams, including R&D, operations, and clinical departments, to embed quality and compliance throughout the organization.
- Manage document control processes for all QA/QC related documentation.
Required Skills
- Strong knowledge of CLIA, CAP, FDA (21 CFR Part 11, 58), ISO 15189/17025, and other relevant laboratory regulations and quality standards.
- Proven experience in Quality Assurance (QA) and Quality Control (QC) within a regulated laboratory environment.
- Excellent analytical, problem-solving, and decision-making abilities.
- Exceptional written and verbal communication skills for report writing, policy development, and training.
- Proficiency in QMS software and document management systems.
- Ability to work independently and manage multiple projects in a remote setting.
- Detail-oriented with a strong commitment to accuracy and quality.
Preferred Qualifications
- Bachelor's degree in Medical Technology, Clinical Laboratory Science, Biology, Chemistry, or a related scientific field.
- Master's degree or professional certification (e.g., ASQ Certified Quality Auditor, ASCP certification).
- Experience with LIS (Laboratory Information Systems) and electronic quality management systems.
- Project management experience in quality improvement initiatives.
Perks & Benefits
- Comprehensive medical, dental, and vision insurance plans.
- 401(k) retirement plan with company match.
- Generous paid time off (PTO) and paid holidays.
- Life insurance and disability benefits.
- Tuition reimbursement and professional development opportunities.
- Employee assistance program.
- Competitive compensation package with performance-based bonuses.
- Flexible, 100% remote work environment.
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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