Job Description

Job Title: Quality Assurance Manager

Job Summary:

The Quality Assurance (QA) Manager is responsible for the laboratory quality, safety, and training programs and manages staff within the QA Department. The QA Manager ensures product safety, product quality, compliance with all relevant regulations, accreditations, certifications, and customer expectations are met. Working cross-functionally, they are drivers of continuous improvement, risk mitigation, and proactive solutions are deployed to ensure alignment with the company’s mission and values. Success is measured in terms of the frequency and scale of product and service quality, organizational issues, as well as business process effectiveness.

Duties & Responsibilities:

• Ensures continuous laboratory licensure and accreditations/certifications through the timely submission of required documentation.

• Maintains knowledge of laboratory regulatory requirements, to include accrediting/certifying bodies, federal, state, and local requirements and provides on-site consultation on quality and/or regulatory issues.

• Meets regularly with department leaders, laboratory managers/supervisors and Medical Directors to implement and monitor the laboratory quality management quality improvement programs.

• Assist departmental managers and medical directors in implementing and maintaining competency and continuing education for staff.

• Provides education to staff regarding laboratory quality management programs and good laboratory practices.

• Continuously monitors quality control and quality assurance is compliant with corporate and regulatory standards

• Compiles, analyzes, and reviews with departmental leaders data related to complaints, nonconforming events, and CAPAs to resolve quality deviations to maintain client and patient expectations of quality.

• Continuously monitors and ensures corporate and personnel adherence to company safety policies, procedures, and federal, state, and county regulatory requirements.

• Compiles Quality Indicator data for routine analysis, and corrective action (when applicable). Quality Indicators are presented and evaluated during routine management reviews.

• Oversees management of electronic quality management system (eQMS), including the maintenance and application of training matrices, and document control, retention, and archival associated activities.

• Conducts internal audits and hosts external client and regulatory audits and inspections. Includes communication and coordination with auditors/inspectors, laboratory SME pre-audit/inspection preparation activities, and submission of post-audit/inspection responses.

• Provides SME guidance and participates in assay development and corporate initiative projects.

• Oversight of and provides SME guidance to ensure assay validation and verification compliance to regulatory and corporate requirements prior to implementation, and associated change control activities.

• Provides leadership and manages assigned department, make decisions, solve problems, develop procedures, conducts and attends meetings.

• Provides Quality guidance and support in the qualification and onboarding of new employees.

• Assist Human Resources in employee development tracks for clinical career paths within the company.

• Promotes the company Mission, Values, and Quality Policy

• Coordinate the maintenance, development and implementation of departmental policies and procedures.

• Support and participate in special company-wide projects

• Must be familiar with and abide by the Corporate Compliance Program and all corporate policies, including the Privacy and Security policies.

• Performs other job-related duties as assigned

Preferred Qualifications:

Education:

• Master’s degree in chemical, physical, biological, clinical laboratory science, medical technology, or regulatory affairs

Experience:

• 5 - 10+ years of experience with high complexity clinical laboratory testing, operating under CLIA/CAP, NYS, ISO regulatory accreditation requirements

• Experience with immunohistochemistry, anatomical pathology, biochemical and molecular clinical testing

• 5+ years of Quality Assurance/Management experience in a high complexity laboratory under CLIA/CAP, NYS, and ISO regulatory and accreditation/certification requirements

• 2+ years of laboratory management experience

• Strong team management skills; experienced in cross-functional collaboration and project management

• Prior administrative experience with MediaLab

Certification:

• MLS, CLS certification or equivalent

• ASQ certified

• Six Sigma certified

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