Heluna Health – Quality Assurance Specialist (Remote/Hybrid) – Richmond, CA

Job title: Quality Assurance Specialist (Remote/Hybrid) Company: Heluna Health Job description: Description : SUMMARY Under the supervision of the Research Scientist Supervisor of the Data, Testing, Epidemiology and Quality Support (DTEQS) Section, the Quality Assurance (QA) Specialist will be responsible for ensuring compliance with Quality Assurance and Quality Control (QA/QC) and safety procedures conducted in the Viral and Rickettsial Disease Laboratory (VRDL) 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 VRDL as defined by Clinical Laboratory Improvement Amendments (CLIA) as well as state regulatory agencies. 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, assay data, reagents, environmental conditions, proficiency testing (PT) and diagnostic results. The salary range for this position is $38.00/hour to $47.21/hour. Must include a resume with the application. If hired for this position, applicant will be required to provide proof of full vaccination for COVID-19 prior to the start date; or have a valid religious or medical reason qualifying the applicant for an exemption (that may or may not require accommodation). ESSENTIAL FUNCTIONS

• Support VRDL 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.
• Develop and maintain shared spreadsheets and databases for tracking Quality Assurance and Quality Control (QA/QC) for the VRDL.
• Investigate and oversee remedial actions for out of compliance results or incidents.
• Communicate with senior leadership regarding process improvement opportunities to streamline the QA/QC program when needed.
• Assist with the VRDL Proficiency Testing (PT) program to ensure compliance with state and federal regulatory requirements. Ensure that the VRDL 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 suggests actions for remedial actions when necessary. Maintain proficiency testing logs and records.
• 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 VRDL 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 VRDL supervisors and section chiefs to compile written and/or verbal responses to deficiencies documented during federal CLIA inspections.
• Assist with leading quarterly QA meetings and reviewing section quarterly QA reports. Maintenance of meeting notes to ensure that all QA/QC needs are addressed in a timely manner. Maintain QA documents and filing system.
• Meet regularly with the CLIA Laboratory Director and/or QA Manager to discuss QA status. Function as the secondary contact for Center for Medicare and Medicaid Services inquiries.

NON-ESSENTIAL FUNCTIONS

• Perform record keeping and other duties as directed by the DTEQS supervisor, QA manager, or CLIA Laboratory Director in the office and laboratory setting.

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
• Possesses analytical and problem-solving skills
• Completes assignments in a timely and efficient manner
• Adheres to departmental policies and procedures regarding attendance, leave, and conduct
• 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/Clearances

• 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 Power Point
• 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 Not Applicable
• Crawl Not Applicable
• Squat or Kneel Occasionally
• Bend Occasionally
• Lift/Carry
• 10 lbs or less Occasionally
• 11-20 lbs Occasionally
• 21-50 lbs Occasionally
• 51-100 lbs Not Applicable
• Over 100 lbs Not Applicable
• Push/Pull
• 12 lbs or less Occasionally
• 13-25 lbs Occasionally
• 26-30 lbs Occasionally
• 41-100 lbs Not Applicable
• Over 100 lbs 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 Combination of Remote and General Office Setting, Indoors Temperature Controlled Must have functioning Wi-Fi/internet access at remote location. 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. Heluna Health is an Affirmative Action, Equal Opportunity Employer that encourages minorities, women, veterans, and disabled to apply. Expected salary: $38 - 47.21 per hour Location: Richmond, CA Apply for the job now! Apply tot his job Apply To this Job