Quality Assurance Manager

We are a premier CLIA Certified and CAP Accredited clinical molecular laboratory. We are dedicated to the diagnostic management of infectious disease, STI/UTI, pharmacogenomics, and COVID-19.

We use our clinical expertise to provide contracted research services for medical device industries. To manage complex disease states, we integrate microbiologic, immunologic, and genomic testing into relevant clinical pathways.

We support the full spectrum of clinical diagnostics, pharmacodynamic monitoring, and companion assay deployment for integrated delivery systems, accountable care organizations, payors, and pharmaceutical companies.

We are a fast-growing laboratory in the Nashville area looking to add to our executive team!

We are offering:

• Consistent Monday-Friday schedule, no evenings required
• Annual Bonuses by end of the year
• Very competitive and flexible base salary for top-level candidates
• 3 weeks paid PTO to go along with 14 paid holidays!!
• Relocation assistance - negotiable based on the move
• 100% paid benefits
• Quick and Efficient interview process

Responsibilities:

• Leads the QA/QC functions to ensure products, processes, and systems meet required quality standards.
• Oversees all aspects of laboratory operations to comply with CLIA, CAP, FDA, OSHA, and other regulatory agencies' requirements and current industry practices.
• Under the oversight of the Laboratory Director, continually assesses and improves education and maintains compliance for CLIA and Medical Laboratory License certification.
• Strengthens the quality culture of the organization, coaches employees on the investigation, root cause analysis, Non-conforming Events (NCE), and Corrective Action Plans (CAPA).
• Oversees quality management specifically quality control, optimal analyzer performance, and maintenance.
• Responsible for quality control daily operations including stability testing, QC inspections and audits, and QC documentation.
• Responsible for the laboratory’s quality system procedures for executing how the company handles process validation, process control and enhancements, quality metric reporting, supplier qualification, design assurance programs, complaint handling, and CAPA programs.
• Reviews and approves reports and other documentation prepared for regulatory submissions/ inspections.
• Acts as a primary quality team member for projects and product teams, providing counsel, training, and interpretation of FDA (when applicable) and other applicable regulations to Company personnel. Seeks appropriate resources as necessary.
• Analyzes, develops, implements, and audits policies and procedures for applicability and compliance with regulations.
• Assists in the development, revision, and implementation of standard operating procedures for the laboratory pertaining to safety, work hazards, and equipment.

Licensure/Certification/Registration (LCE):

Required credential(s):

• Certified Molecular Biotechnologist (MB), Medical Laboratory Scientist (MLS), or Medical Technologist (MT) prior to hire date.
• Licensed Medical Laboratory Scientist (MLS) or Medical Technologist (MT) from the Tennessee Medical Laboratory Board obtained within six months or 180 days from the hire date.
• A Tennessee state supervisor’s license is required.

Education: Bachelor’s Level Degree.

• Bachelor’s degree in medical laboratory science/technology from CAHEA or NAACLS accredited medical laboratory science program, or physical, chemical, or biological science is required. A Tennessee state supervisor’s license obtained prior to September 1, 1997, is acceptable in lieu of the degree requirement.
• Equivalent education and experience per CLIA and the Tennessee Medical Laboratory Board (1200-06-1-.21) for personnel performing high complexity testing, AND ASCP medical laboratory scientist generalist or categorical certification, or equivalent certification.

Work Experience:

• At least three years of Clinical Laboratory supervisory experience is required.