SUMMARY The Infectious Disease Laboratory Division (IDLD) is currently seeking a highly motivated Quality Assurance (QA) Specialist to join the Genomics Center group.

Under the supervision of the Genomics Center Manager, the QA Specialist will be responsible for ensuring compliance with Quality Assurance and Quality Control (QA / QC) and safety procedures conducted in IDLD and may be delegated responsibilities as a Clinical Laboratory Improvement Amendments (CLIA) General Supervisor and Technical Supervisor over non-waived, high-complexity testing performed in the Genomics Center facility as defined by CLIA as well as state regulatory agencies.

The Genomics Center QA Specialist will assist coordinating QA-related tasks among laboratory staff and manage administrative duties that support the laboratory's daily operations to ensure all aspects of laboratory operations comply with regulatory standards.

Duties will include providing technical oversight and implementation of uniform Quality Control standards for laboratory equipment, personnel, Standard Operating Procedures (SOPs), assay validations and verifications, data management, reagents tracking, environmental conditions, proficiency testing (PT) and diagnostic results.

Must submit a resume with the application. Must be able to work flexible hours that may include weekends and holidays. The hourly range for this position is $35.

00 to $44.00 per hour depending on experience / qualification. ESSENTIAL FUNCTIONS

Support IDLD staff with coordinating laboratory equipment preventative maintenance (PM) and calibration services.

Serve as the primary point of contact for equipment maintenance appointments.

Maintain calibration / certification of laboratory equipment.

Arrange for professional services as needed and maintain records for service requirements, and documentation of compliance.

• Manage laboratory administrative duties, including inventory and asset management, to support daily laboratory operations and ensure compliance with regulatory standards.
• Responsible for maintaining all Quality records from internal and external audits of IDLD and report findings while consistently following inspection requirements.

Investigate and oversee remedial actions for out of compliance results or incidents.

Assist with the IDLD Proficiency Testing (PT) Program to ensure compliance with state and federal regulatory requirements.

Ensure that the IDLD completes annual external and internal PT programs.

Responsible for viewing and submitting PT results, review results and scores of proficiency testing with section supervisors and chiefs, oversee and suggest actions for remedial actions when necessary.

Maintain proficiency testing logs and records.

• Develop and maintain shared spreadsheets and databases for tracking Quality Assurance and Quality Control (QA / QC) for the IDLD.
• Communicate with senior leadership regarding process improvement opportunities to streamline the QA / QC program when needed.
• Assist unit supervisors with diagnostic test validation / verification protocols and Standard Operating Procedures (SOPs) as mandated by CLIA.
• Function as regulatory expert and provide guidance to senior leadership and IDLD staff regarding federal and state regulations governing laboratory accreditation and certification.
• Function as the one of the lead regulatory experts during biennial CLIA accreditation visits by compiling the necessary documents to present to CLIA inspectors and ensuring the laboratory QA / QC program within the testing units meets the federal requirements.

Work with IDLD supervisors and section chiefs to compile written and / or verbal responses to deficiencies documented during federal CLIA inspections.

Meet regularly with the CLIA Laboratory Director and / or research supervisors to discuss QA status.

Function as the secondary contact for Genomics Center inquiries.

• Ability to assist with other IDLD activities / testing in other sections to enhance capacity during laboratory surges. JOB QUALIFICATIONS
• Incumbent must be able to communicate effectively (orally and in writing if both appropriate) in dealing with the public and / or other employees
• Completes assignments in a timely and efficient manner
• Adheres to departmental policies and procedures regarding attendance, leave, and conduct
• Prior experience maintaining a quality system, according to the CLIA regulations, California laboratory regulations is required
• Experience in DNA Sequencing in a CLIA laboratory, sequencing facility, or genomics core environment highly desired
• High-level proficiency with MS Excel; experience with SharePoint and database programs such as MS Access preferred Education / Experience
• Bachelor’s degree in a biological science, with course work in chemistry, microbiology, and molecular biology, required
• Previous experience working or volunteering in a public health setting preferred, but not required
• Prior experience in laboratory quality assurance preferred, but not required. Certificates / Licenses
• Qualification as a Technical Supervisor in accordance with CLIA preferred, but not required
• Public Health Microbiologist certification preferred, but not required Other Skills, Knowledge, and Abilities
• Knowledge of and skilled in the use of Microsoft Office products including Word, Excel, Access, Outlook, and PowerPoint
• Strong organizational and communication skills
• Possesses keen attention to detail PHYSICAL DEMANDS
• Stand : Frequently
• Walk : Frequently
• Sit : Frequently
• Handling / Fingering : Frequently
• Reach Outward : Occasionally
• Reach Above Shoulder : Occasionally
• Climb, Crawl, Kneel, Bend : Occasionally
• Lift / Carry : Occasionally - Up to 30 lbs
• See (Vision) : Constantly
• Taste / Smell : Not Applicable KEY
• Not Applicable Not required for essential functions
• Occasionally (0 - 2 hrs / day)
• Frequently (2 - 5 hrs / day)
• Constantly (5 hrs / day) WORK ENVIRONMENT General office and laboratory setting, indoors, temperature controlled EEOC STATEMENT It is the policy of Heluna Health to provide equal employment opportunities without regard to race, color, religion, sex, national origin, age, disability, marital status, veteran status, sexual orientation, genetic information or any other protected characteristic under applicable law.

Equal Opportunity Employer / Protected Veterans / Individuals with Disabilities The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant.

However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information.

41 CFR 60-1.35(c)

Last updated : 2024-08-27