What are the responsibilities and job description for the Manager Quality Assurance - Lab Operations position at Abbott?
The Opportunity
The position of Manager, Quality Assurance is within our Toxicology business unit located in Gretna, LA . The Quality Manager is responsible for the implementation, maintenance, and continuous improvement of the laboratory Quality Management System, ensuring that laboratory testing is performed in compliance with all applicable regulations and certifications, including, but not limited to, CAP, SAMHSA, and CLIA. The role requires a dynamic and self-motivated professional with a demonstrated ability to influence change. Mastery of data necessary to influence fact and risk-based decisions and to demonstrate measured outcomes is a key requirement of the role. This role will be instrumental in providing quality results to our clients.
What You’ll Work On
Develop, implement, and maintain laboratory quality processes and procedures, in compliance with applicable laboratory regulations and Rapid Diagnostic policies.
Develop mechanisms to identify compliance gaps and facilitate remediation activities where necessary utilizing risk-based prioritization.
Regularly report on quality and regulatory performance, including trending and analysis of deviations and non-conformance, to inform laboratory quality objectives, priorities, and improvements.
Keep abreast of new or changing quality and regulatory practices and standards within the industry and coordinate development of or update laboratory compliance standards, guidelines and programs as appropriate.
Support or participate in internal, client and regulatory agency audits to ensure compliance with certification requirements, laws, regulations, policies and procedures. Includes routine audit of laboratory departments for compliance with company quality policy and procedure and CLIA, and State requirements where applicable.
Carries out duties in compliance with established BU and AQR practices, policies, and processes and provides subject matter expertise to drive improvements and decisions relating to quality management systems.
Leverages quality metrics to identify risks for the organization in order to direct and support development / implementation of policy, procedure, training, and other available tools for reducing identified risks.
Ensures laboratory licensure is maintained through periodic renewals, new applications, method submissions and managing the proficiency testing program.
Direct and perform internal and external audits related to regulatory, accreditation agencies and business partners. Demonstrate ability to maintain excellent positive relationships with auditors or regulatory agencies.
Administer and manage the document control system, incident reporting system and personnel documentation.
Ensure that Quality Control and Quality Assessment programs are established and maintained to identify failures in quality as they occur.
Assist with development, implementation and maintenance of effective departmental QA programs and monitors.
Assure that QA reviews are effective at identifying and preventing errors, and that corrective actions are followed up for effectiveness.
Review alllaboratory proceduresand validation documentation for compliance following regulation and guidance.
Monthly patient test management responsibilities include randomly selecting specimens for review of all external and internal COC, specimen label and test data records associated with these specimens including specimen reports (Tox2 and web) to ensure proper handling of patient specimens and test data.
Oversee and manage quality system related meetings, collect and trend key performance indicators.
Review, report and action key quality metrics on routine basis including, but not limited to, Problem Specimens Log, Percent Positive Report, Audit Reports, CAPA and Nonconformance data, etc.
Investigate unanticipated incidents that deviate from documented laboratory processes via the occurrence reporting system. Initiate CAPAs, as appropriate, to address system deficiencies and drive implementation of corrective action plans.
Address quality concerns raised by customers or identified internally.
Request and maintain all vendor documentation.
Demonstrates commitment to thedevelopment, implementation andeffectiveness of Quality Management System per ISO, FDA, and other regulatory agencies.
Understands and is aware of the quality consequences which may occur from the improper performance of their specific job. Has awareness of device defects that may occur in their area of responsibility, including product design, verification and validation, manufacturing and testing activities
Required Qualifications
BA / BS Degree in Chemistry, Biology / Medical Technology or other related field
7 years in a toxicology laboratory setting, including 3 years in a Quality / Regulatory environment
Experience developing Lab Quality Management Systems and managing lab audits
Knowledge of 1988 Clinical Laboratory Amendments (CLIA '88) - federal certification requirements and State, Federal Accrediting Agency standards.
Experience as a people manager
Work in a cross-functional environment, achieving regulatory compliance though teamwork, facilitation and influence .
Ability to interpret regulatory agency requirements and to converting these into practical and pragmatic actions.
Strong written and verbal communication skills, including ability to articulate complex regulatory / quality arguments.
Organized and attentive to detail, strong interpersonal skills and capable of providing support and direction to others.
Preferred Qualifications
Professional certification is preferred (i.e. CQA, Six Sigma, CQM)
