QA/QC Manager

Job Posting Title
QA/QC Manager

Agency
340 OKLAHOMA STATE DEPARTMENT OF HEALTH

Supervisory Organization
340 Public Health Lab Service

Job Posting End Date (Continuous if Blank)
December 09, 2024
Note: Applications will be accepted until 11:59 PM on the day prior to the posting end date above.

Estimated Appointment End Date (Continuous if Blank)

Full/Part-Time
Full time

Job Type
Regular

Compensation
The annual salary for this position is Up to $89,596.52 based on education and experience.

Why you’ll love it here!

RESPECT. COLLABORATION. SERVICE. The Oklahoma State Department of Health (OSDH) is committed to leading Oklahoma to prosperity through health. Our mission is to protect and promote health, prevent disease and injury, and cultivate conditions by which Oklahomans can thrive. Check out why we are passionate about public health and believe it is the career for you!!!

Oh yeah, did we mention perks? We know that benefits matter and that is why we offer a competitive benefits package for all eligible employees.

• Generous state paid benefit allowance to help cover insurance premiums.
• A wide choice of insurance plans with no pre-existing condition exclusions or limitations.
• Flexible spending accounts for health care expenses and/or dependent care.
• Retirement Savings Plan with a generous match.
• 15 days of vacation and 15 days of sick leave the first year for full time employees.
• 11 paid holidays a year.
• Student Loan repayment options & tuition reimbursement.
• Employee discounts with a variety of companies and venders.
• Longevity Bonus for years of service

Job Description

Location: Stillwater - 4615 W Lakeview

Salary: Up to $89,596.52

Full Time /Part Time: Full Time

Work Schedule: Monday - Friday

Primary Hours: 8:00 am - 5:00 pm

Position Description:

This position provides managerial oversight to maintain compliance in quality assurance and quality control and biosafety procedures to meet and exceed CLIA, CAP, and all regulatory requirements required for operation of a high complexity laboratory testing facility. Other duties include training staff to be active participants in the laboratory’s quality system. Along with leadership, this position is assigned key responsibilities involving technical coordination and collaboration of the comprehensive laboratory systems to ensure provision of state-wide, clinical diagnostic, surveillance and/or analytic testing services. This role will also be responsible for the oversight of the laboratory biosafety program and the Accessioning, Shipping and Receiving section within PHL in support of the laboratory’s Chemical Terrorism response in Oklahoma.

Duties:

Duties include, but are not limited to:

• Reports to the Lab Director and CLIA Director for prioritization of assigned duties.
• Responsible for service line performance and compliance with safety initiatives, federal, state, and other regulatory bodies including but not limited to CLIA, CAP, JC, OSHA, CMS, CDC, ISO, EPA, and other department-specific accrediting and certifying bodies.
• Leads meetings and compiles lab-wide quality indicators on a quarterly basis to monitor the ongoing quality and performance of all testing operations.
• Develops and oversees the clinical laboratory safety program, coordinates evaluation of safety incidents, and ensures ongoing assessment of the safety program's effectiveness.
• Works independently while managing complex quality assurance and quality control processes as a designated representative of the CLIA Lab Director.
• Ensures the development, implementation, and use of an effective document control program to include on-site hard copy and digital documentation.
• Communicates QA/QC processes as they relate to testing, test menu, LIMS, and other lab capabilities to appropriate persons including staff, external staff, vendors, clients, and inspectors.
• Ensure validations and proficiency testing occurs and appropriate documentation is readily available including self-inspections, ongoing quality audits, and staff proficiency testing including evaluation of results, root cause analysis when indicated, and implementation of corrective actions.
• Assist with specific testing procedures to ensure they meet or exceed CLIA, CAP, and other appropriate guidelines.
• Oversees project development for new quality programs used throughout the laboratory including the identification of processes in need of correction and recommend solutions, document time frames, and outcomes.
• Review and update laboratory SOPs. Write new SOPs as required.
• Supports metric gathering, interprets data, creates assessments of performance for lab departments, and communicates efficiencies and deficiencies.
• Supports the Laboratory’s Select Agent Program as a Responsible Official, as needed.
• Other duties as assigned by the Lab Director and CLIA Director.

Other Duties

• Demonstrates knowledge of and supports mission, vision, value statements, standards, policies and procedures, operating instructions, confidentiality standards, and the code of ethical behavior.
• Works effectively in team environment, participating and assisting their peers.

This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Responsibilities, duties, and activities may change at any time with or without notice.

Minimum Qualifications:

Bachelor's degree in Medical Technology or a Life Science required; Previous experience as a quality analyst/quality manager/MT/MLT/CLS in clinical laboratory/environmental laboratory/health industry settings required; General knowledge of laboratory regulations (CAP/CLIA) and/or FDA licensing requirements; Strong understanding of audit related requirements and procedures; Working knowledge of quality assurance/quality management best practices; Excellent analytical, critical thinking and problem-solving skills; Strong communication skills; both written and verbal; High level of attention to laboratory details with strong organizational skills; Ability to work independently and within a team environment.

Valued Knowledge, Skills and Abilities

Knowledge of the advanced principles of chemistry, biochemistry, immunology and/or microbiology; of CLIA, CAP, and other entities who oversee clinical lab setting; of chemical, biochemical, immunological, and/or microbiological laboratory techniques and procedures; Experience in observing and correcting the hazards of laboratory activities and communicating safety procedures. Ability to manage the quality assurance and quality control aspects; to collaborate with intra- and inter-agency programs and lab leadership in testing related decision-making processes; to collaborate and coordinate technical processes and procedures through maintaining effective working relationships; and to exercise initiative and independent judgment. Knowledge of laboratory principles and techniques in high complexity testing across multiple disciplines and assays. Ability to plan and coordinate the work of a laboratory with other services and programs within the agency and between state and federal agencies.

Application Requirements:

• If education, certification or licensure is required to meet qualifications, applicants must provide documentation at the time of application.
• All applicants are subject to a background check and must be legally authorized to work in the United States without visa sponsorship.

Physical Demands and Work Environment:

This position is set in a laboratory environment. While performing the duties of the job, employees are frequently required to stand, walk, lift, and reach while wearing appropriate PPE.

Telework:

This position is not eligible for telework and is subject to OSDH policy and supervisor’s discretion.

Equal Opportunity Employment

The State of Oklahoma is an equal opportunity employer and does not discriminate on the basis of genetic information, race, religion, color, sex, age, national origin, or disability.

Current active State of Oklahoma employees must apply for open positions internally through the Workday Jobs Hub .

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• Oklahoma State Department of Health

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