Laboratory Quality Assurance Lead

LLNL•Livermore, CA

1d•Hybrid

About The Position

We have an opening for a Laboratory Quality Assurance Lead. You will work with Environment, Safety & Health (ES&H) Analytical Services and Instrumentation (AS&I) to ensure environmental, industrial hygiene and radiological analytical data and processes meet appropriate quality assurance and quality control standards. This position acts as a designated Quality Assurance Manager/Lead for multiple accreditation programs including ISO-17025, AIHA-LAP, CA ELAP, TNI, and Department of Energy Laboratory Accreditation Program (DOELAP). This position is in the Technical Services Department. This position will be filled at either level based on knowledge and related experience as assessed by the hiring team. Additional job responsibilities (outlined below) will be assigned if hired at the higher level. This position may offer a hybrid schedule, which includes the flexibility to work from home one or more days per week, after a probationary period.

Requirements

Ability to secure and maintain a U.S. DOE Q-level security clearance which requires U.S. citizenship.
Bachelor’s degree in chemistry, radiochemistry, nuclear chemistry, or other closely related applied science, or the equivalent combination of education and significant related experience and demonstrated ability to lead independent work.
Proficient experience administering quality management systems for analytical and calibration laboratories, such as ISO 17025, AIHA-LAP, California State Environmental Laboratory Accreditation Program (CA-ELAP), TNI 2016 or DOELAP.
Demonstrated ability to guide multiple levels of staff in the implementation and maintenance of associated QMS activities including leveraging laboratory information management systems (LIMS) to complete QMS activities.
Ability to review and interpret complex technical data generated by the analyses or calibrations performed in environmental, industrial hygiene, external dosimetry, radiation spectroscopy, or radiochemical laboratories.
Experience utilizing advanced analytical, decision-making, and problem-solving skills to evaluate, interpret, negotiate, recommend, and implement actions/solutions to complex problems.
Effective and efficient organizational skills to coordinate multiple and frequently conflicting, concurrent tasks, with frequent interruptions and changing priorities.
Significant experience determining long and short-term project objectives with limited consultative direction, working independently and in a team environment with a broad cross-section of people and organizations, managing complex projects, and meeting schedules.
Advanced verbal and written communication skills necessary to effectively collaborate in a team environment and present and explain technical information and provide advice to all levels of scientific staff, management, and external collaborators.
Substantial experience concurrently administering multiple (two or more) highly complex quality management systems for environmental or public health analytical laboratories.
Experience planning for, designing, and obtaining initial accreditation which did not previously exist for a laboratory.
Highly advanced experience required to prepare control charts, design calibration procedures, interpret and negotiate accreditation requirements, and communicate the business case to management.

Nice To Haves

Experience with two or more of the following: radiation calibration or industrial hygiene calibration equipment, personnel dosimetry, alpha spectroscopy, gamma spectroscopy, gas proportional, liquid scintillation counting, inductive coupled plasma emission spectroscopy (ICP-OES), gas chromatography mass spectroscopy (GC-MS) instrumentation.
Experience administering quality assurance programs in DOE or other governmental programs.
Experience managing an AIHA-LAP quality assurance program.
Experience working in a DOELAP accredited laboratory.

Responsibilities

Provide oversight and direction to ensure that ES&H AS&I laboratories are compliant with applicable AIHA-LAP, CA ELAP, ISO-17025, TNI and DOELAP requirements to maintain the accreditations.
Administer a comprehensive approach for a standardized Quality Management System that requires management of multiple QA plans and numerous SOPs implementing QA requirements in eight laboratories.
Interpret and translate regulatory and contractual quality requirements into actionable program-level controls.
Ensure quality policies, procedures, and work instructions are current, controlled, and effectively deployed.
Prepare and perform annual reviews of accreditation checklists/internal audits based on accreditation standards.
Prepare internal unknown QC samples as required by the applicable QC procedures.
Prepare accreditation applications to the accrediting bodies.
Interface with accrediting bodies and Livermore Field Office, and act as point of contact for all accreditations.
Coordinate and facilitate multiple on-site accreditation assessments.
Coordinate and lead management reviews for all accredited laboratories. Prepare agenda and conduct meetings. Document and implement action items.
Lead QA Core team meetings for all accredited laboratories on a predefined cadence.
Prepare and present compliance status to senior management and program leadership.
Prepare nonconformance reports and support associated investigations and corrective actions.
Develop and implement corrective action plans.
Perform other duties as assigned.
Provide expert quality assurance guidance and direction to management, laboratory staff, and technical leaders.
Integrate quality risk management principles into program planning and execution.
Lead implementation, maintenance and continuous improvement of the organizational Quality Management System in alignment with all applicable requirements.
Review institutional and directorate QMS documents and provide feedback.
Ensure compliance with institutional and directorate policies and procedures.