Quality Assurance Supervisor

Founded by an executive team with experts from laboratory and substance treatment programs, Star Labs fills a void that was missing in the testing space. With over 50 years of experience, we provide a sound connection between premier, high quality customer service, and flawless operational efficiency. Our team generates unsurpassed value to the betterment of clinical care.

Our primary focus is to provide the best service possible to our patients and clients. We are the missing link connecting small business customer service and large business operation in the laboratory testing industry. Star Labs has established an open line of communication with our client community where we learn, adapt, and grow to effectively meet our customers’ needs.

Job description

Star Labs is looking for a part-time Quality Manager for its High-Complexity Testing CLIA Laboratory. The Quality Manager will provide quality and compliance oversight to the diagnostic testing laboratory. This is a highly specialized role that requires the ability to apply CLIA requirements across the laboratory. This position will lead the quality management program for the CLIA laboratory in accordance with the regulatory standards and the quality management system at Star Labs. The Quality Manager will collaborate with direct and/or delegated authority to ensure the CLIA Quality Management Systems (QMS) are effective and compliant with applicable requirements, provide leadership and guidance regarding CAP/CLIA, NJDOH, NYSDOH and associated regulations, and support the Lab Director and leadership in maintaining audit readiness.

Position Responsibilities • Maintain Licensure by ensuring all CLIA and state licenses are renewed in a timely manner. • Implement CAP (College of American Pathologists) testing and any required reporting. • Along with the Lab Director, Technical Director, and leadership, maintain laboratory audit readiness by overseeing and managing clinical lab audits with regulators, ensuring that internal system and process audits are scheduled and conducted. • Lead and coordinate timely resolution of any audit findings. • Lead the CLIA Quality Management Program to maintain and improve a QMS that is compliant with the applicable regulations and standards. • Lead and monitor deviations and corrective and preventative actions, ensuring a timely resolution and thorough documentation. • Responsible for monthly reporting of significant issues or trends related to quality of activities for which the clinical laboratory is responsible. • Ensure lab systems are performed in compliance with regulations, including IQ/OQ/PQs, calibrations, maintenance, and concordance, etc., • Identify, assess, and manage quality risks or compliance concerns proactively and take immediate corrective action as required. • Work with the Lab Director to ensure the timely and compliant generation of validation/verification data required to support regulatory submissions for all new tests and modifications to existing tests. • Ensure documentation of personnel qualifications, competency, and trainings are managed and maintained. • As part of CAP or other external proficiency testing programs, ensure records are complete and accurate to include, enrollment, documentation and performance monitoring. • Review all new and revised standard operating procedures, including periodic review. Establish and maintain standard operating procedures for CLIA quality & compliance. • Provide leadership and be a resource to staff regarding CLIA and related regulations and best practices, including maintaining knowledge of applicable regulations, providing consultation to staff regarding regulatory compliance.

Job Type: Part-time • 8-hour shift • 2-3 days/week • Work Location: In person, on-site (Piscataway, NJ). No option to work remotely.

Qualifications

· BS degree in medical technology, laboratory sciences or scientific disciplines

· Minimum 6 years’ experience in CAP/CLIA laboratories performing high complexity testing.

· Minimum of 4 years’ experience in Quality Assurance (QA), accreditation requirements and applicable regulations pertaining to CLIA laboratories. Knowledge of NJDOH and NYSDOH regulatory requirements required.

· Experience in QA oversight of Chemistry and Immunochemistry departments of the laboratory required. Toxicology, Hematology, and/or Molecular Diagnostic experience strongly preferred.

Job Type: Part-time

Schedule:

• 8 hour shift

Education:

• Bachelor's (Preferred)

Experience:

• Quality assurance: 4 years (Required)
• qa oversight of chemistry and immunochemistry departments: 1 year (Required)
• toxicology, hematology and/or molecular diagnostic: 1 year (Required)
• CAP/CLIA: 6 years (Required)

Ability to Commute:

• Piscataway, NJ 08854 (Required)

Ability to Relocate:

• Piscataway, NJ 08854: Relocate before starting work (Required)

Work Location: In person