Quality Assurance Officer - Health & Environmental Testing Laboratory
About The Position
This position is responsible for assisting in the continuing development of the laboratory quality assurance program for the Clinical Microbiology Department. The role involves providing training, performing audits, investigating and documenting performance issues, and evaluating the effectiveness of corrective actions to improve testing services as required by CLIA, federal CDC, Maine CDC, and the Health and Environmental Testing Laboratory (HETL). The Quality Assurance Officer will also serve as the U.S CDC’s Laboratory Response Network (LRN) Laboratory Program Advisor, requiring extensive interaction with private and federal entities such as hospital laboratories and the U.S CDC. Duties include conducting periodic state-wide visits to hospital laboratories to assess testing capability and capacity, ensuring they are up-to-date on analytical methods for identifying agents of bioterrorism. The role also ensures the HETL has the analytical capability to test for these agents and maintains compliance with responsible sections of the Federal Select Agent Rules.
Requirements
- A Bachelors Degree in Medical Technology or chemical, physical, or directly related life science and six (6) years of clinical laboratory experience.
- Comparable experience may be substituted for education on a year-for-year basis.
Nice To Haves
- Professional certifications such as ASCP, MLT, or MT
- Knowledge or experience with federal laboratory accreditation programs such as CLIA or CAP
- Extensive technical knowledge of serology, bacteriology, virology, molecular, biology, and histology laboratory methods
- Ability to establish and maintain effective working relationships with a diverse group of internal and external partners
Responsibilities
- Oversight of quality assurance and quality control measures in the Clinical Microbiology section within HETL
- Review of CLIA guidelines to assure laboratory compliance
- Review of IQCP/QA/QC metrics for all standard operating procedures (SOPs)
- Oversight of CLIA competencies and proficiencies to assure annual completion
- Preparation of all documents for CLIA inspections
- Developing and coordinating monthly QA Committee meetings with clinical and LRN Staff
- Developing and coordinating quarterly meetings with the Epi-Lab Work Group
- Managing non-conformance programs using quality notification forms and corrective action reports
- Coordination with the Laboratory Safety Officer and Biosafety Officer
- Partnering with the Maine CDC and state groups on emergency preparedness
- Managing and coordinating an outreach program with all Sentinel laboratories for sample submissions, workflows, and post-analytical processes for all patient testing
- Providing assessment and evaluation of Sentinel laboratory capability and capacity to facilitate LRN response
- Managing proficiency testing for CDC assessment of Maine's capability to monitor for biological agents of Weapons of Mass Destruction (WMD)
Benefits
- 13 paid holidays
- 3+ weeks of vacation leave annually
- 12 days of sick leave per year
- Health Insurance Coverage (State pays 85%-95% of employee-only premiums)
- Health Insurance Premium Credit (Participation decreases employee-only premiums by 5%)
- Dental Insurance (State pays 100% of employee-only dental premiums)
- Retirement Plan (State contributes 14.06% to MainePERS)
- Gym Membership Reimbursement (up to $40 per month)
- Health and Dependent Care Flexible Spending Accounts
- Public Service Student Loan Forgiveness eligibility
- Living Resources Program (employee assistance program)
- Six weeks of fully paid parental leave
- Voluntary Deferred Compensation (MaineSaves 457(b) account)
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
