Lab Compliance Officer
About The Position
Performs work corresponding to the activities within the Quality Assurance and Improvement Office, Radiation Control, and the Laboratory Licensure and Certification Office. Assists or determines the issuing of licenses to laboratories (Medical Marijuana, Environmental, Clinical), maintaining current licenses (EPA, CLIA, ISO/IEC) for ASPHL by ensuring the minimum standards of proficiency, methodology, quality assurance, operation and safety, and ensuring compliance with ionizing and non-ionizing radiation. Conducts initial and annual inspections of laboratories, ionizing and non ionizing facilities to determine compliance with the Statutes or Rules. Review of quality systems by tracking documents, corrective actions, and other quality data. Conducts investigations of the operation of a licensed laboratory upon receiving a complaint or of an unlicensed laboratory performing compliance testing. This position is required to perform work at/attend meetings at alternate locations and/or travel (in and out of state) when necessary, possibly requiring a state, personal or rented vehicle. Corresponds with the regulated lab community or with regulatory bodies, responds to technical questions from the laboratories, development of standards, rule making and laboratory inspections. Perform, assist or review detailed investigative or inspection reports, statements of deficiencies, and correspondence regarding changes in the status of a laboratory's certification, or other types of legal orders. Is recognized as an expert in own area within the organization. Has specialized depth and/or breadth of expertise in own discipline or function. Interprets issues and recommends solutions or best practices. Solves complex problems, taking a broader perspective to identify solutions. Acts as a resource to lower level colleagues. May lead functional teams or projects
Requirements
- Federal regulations and Arizona Revised Statutes related to, laboratory testing, general laboratory procedures, good understanding of laboratory management and operational concepts, specialized laboratory procedures, laboratory safety precautions emphasis when working with infectious agents and/ or hazardous materials.
- Performance Management (PM), and Continuous Quality Improvement (CQI) and Lean methodologies.
- Review and reading of professional literature, requires high level of oral and written communication, analytical review, interpersonal relationships, active listening, organizational, evaluation, repetition, education/training
- Change priorities as issues arise, problem solving (root cause), work independently, perform reviews of laboratory testing, analyze analytical data, reporting, and evaluation of analyst qualifications providing compliance data.
- Support a diverse multi-cultural workforce that reflects the community, promotes equal opportunity at all levels of public employment, and creates an inclusive work environment that enables all individuals to perform to their fullest potential free from discrimination.
- Must have driver’s license and ability to travel
- State, Federal or National certification/ approval for appropriate field(s); must be obtained within 1 year of employment.
Nice To Haves
- Minimum Bachelor's degree in laboratory science plus 5+ years experience appropriate/relevant in lab field or LCO I plus 2+ years inspection experience.
Responsibilities
- Conduct inspections of laboratories to determine compliance with statutes, rules and internal procedures.
- Monitor and/or review quality systems assigned for specific discipline. Review of quality systems by tracking documents, corrective actions, and other quality data.
- Participate and/or lead staff, advisory committee, and/or laboratory organization (e.g. APHL, AOAC, etc.) meetings
- Develop standard and ad hoc reports, templates, dashboards, and other performance-related metrics.
- Independently conduct investigations if significant issues are identified or complaints received.
- Set up and lead inspections.
- Schedule and oversee training for new employees and or Provide advice and guidance to lower-level worker.
- Requests and responds to feedback from clients on services.
- Other duties as assigned as related to the position.
Benefits
- Affordable medical and dental insurance plans
- Paid vacation and sick time
- Paid Parental Leave-Up to 12 weeks per year paid leave for newborn or newly-placed foster/adopted child (pilot program).
- 10 paid holidays per year
- Wellness program and plans
- Life insurance
- Short/long-term disability insurance
- Defined retirement plan
- Award winning Infant at Work program
- Credit union membership
- Transit subsidy
- ADHS Student Assistance Pilot Program
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
