Laboratory Quality Assurance Manager

Job Summary

The Laboratory Quality Assurance Manager is responsible for supervising the laboratory process to make sure that all data generated from LDTs meet consistent standards. Their duties include developing and implementing quality control processes, inspecting results at various stages and writing reports documenting workflow issues. They will serve as the primary contact with regulatory authorities and clients during audits and inspections

Duties and Responsibilities

General Responsibility

• Develop and maintain the Laboratory’s Quality System.
• Assist with laboratory regulatory duties.
• Maintain smooth laboratory workflow.
• Obtain lab certifications and complete QA/QC assignments.
• Promote good customer relations with all Functional Fluidics clients.
• Other duties as assigned.

Job Tasks

• Maintain the Laboratory’s Quality Management System
• a. Ensure consistent implementation, review, and governance of SOPs, policies, and controlled documents.
• b. Perform and document corrective action, including follow-up monitoring to gauge the effectiveness of the corrective action.
• c. Lead internal audit program
• d. Oversee external assessments, proficiency testing programs; document control systems; competency assessment; training and other quality processes.
• Develop, improve, report, and summarize validations and verifications of proprietary and commercial assays and methods.
• Ensure that there is an effective system to control and manage documents and records.
• Ensure timely escalation of compliance risks and implementation of corrective and preventive actions (CAPA)
• Translate regulatory requirements into practical, operational quality controls.
• Maintain oversight of data integrity programs, result corrections, and documentation standards.
• Ensure compliance with laboratory accreditation, regulatory standards and information management policies by providing leadership and guidance to staff to ensure that quality policies, processes and procedures are established, current and adhered to by all laboratory staff.
• Recommend best practices to maintain and improve project outcomes or laboratory functions; facilitate laboratory and quality improvement activities.
• Analyze data, identify trends, monitor prevention and correction of quality deviations, and develop reports for management utilizing technical knowledge and laboratory experience.
• Identify and report quality issues and problems to management with recommendations for resolution.
• Establish processes and policies for effective and professional communication between laboratory staff and among other interested parties.
• Work with the safety officer and security/biosecurity officer to align quality practices, including data analysis, monitoring of trends, prevention, corrections and continuous quality improvement.
• Analyze quality data and KPIs to drive process improvement initiatives.
• Facilitate monthly and quarterly quality metrics reviews and management reviews.
• Support vendor qualification, oversight, and issue resolution.
• Ensure that laboratory personnel and instrumentation meet performance standards.
• Ensure that operational processes meet organizational requirements through the application of workflow processes or the development of method validation and performance verification processes and procedures.
• Demonstrate knowledge and skills related to the scientific and technical components of laboratory testing in order to oversee the policies, processes and procedures related to QA activities.
• Comply with regulations and guidelines governing laboratory testing, ensuring staff compliance and evaluating method validation and performance verification results.
• Promote good customer relations with all Functional Fluidics clients.
• Maintain good customer relations at all times, including:
• a. Maintaining a professional appearance
• b. Being polite and courteous to all clients in person and on the telephone
• c. Promoting Functional Fluidics laboratory services
• d. Providing appropriate paperwork and containers to customers as needed
• e. Answering customer questions or direct questions to appropriate personnel

Qualifications

• Formal Education: at least a Bachelor’s degree in biological, chemical, or physical science related field (or equivalent including medical or clinical laboratory science and medical technology).
• Work Experience: Minimum of 3-5 years of recent related laboratory work experience in a certified (e.g., CLIA, CAP, EPA, NELAC) clinical, research, or public health laboratory. 8 years in regulated environment (GLP/GCP role) preferred.
• Demonstrated experience managing quality in a CLIA, COLA, CAP, or NY accredited laboratory.
• Strong working knowledge of laboratory quality systems and regulatory standards.
• ASCP certification in Hematology or as MLS strongly preferred.
• Must meet all state and federal requirements for education and experience as mandated by CLIA, CAP, CA, and NY regulations.
• Working knowledge of computer and analytical software programs to evaluate electronic data, data interpretation, and report development.

Working Conditions

It is reasonable to anticipate exposure to bloodborne pathogens and/or hazardous chemicals in this position.

Personal Qualities

• Ability to work with limited supervision.
• Strong attention to detail.
• Good verbal and written skills.
• Positive attitude.
• Ability to work well with others.
• Willing to accept additional responsibilities.
• Ability to sit or stand for extended periods of time.
• Good eye/hand coordination and dexterity.
• Ability to appropriately dress to avoid exposure to bloodborne pathogens and bodily secretions.
• Strong initiative.

Physical Requirements

• Ability to climb stairs.
• Ability to lift 35lbs.
• Visual and auditory acuity.
• Ability to walk and bend down.

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