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Quality Assurance Specialist

Company: Public Health Foundation Enterprises, In
Location: Richmond
Posted on: November 22, 2022

Job Description:

SUMMARY
The Infectious Disease Laboratory Branch (IDLB) is currently seeking a highly motivated Quality Assurance (QA) Specialist to join the Genomics Center group. The QA Specialist will be responsible for ensuring compliance with Quality Assurance and Quality Control (QA/QC) and safety procedures conducted in IDLB and may be delegated responsibilities as a Clinical Laboratory Improvement Amendments (CLIA) General Supervisor and Technical Supervisor over Next-Generation Sequencing testing performed in the Genomics Center 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.
Must submit a resume with the application.
Must be able to work flexible hours that may include weekends and holidays.
If hired for this position, applicant will be required to provide proof of full vaccinated 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). The applicant will need to have the qualifying exemption.
ESSENTIAL FUNCTIONS
Support IDLB 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.
Responsible for maintaining all Quality records from internal and external audits of IDLB and report findings while consistently following inspection requirements. Investigate and oversee remedial actions for out of compliance results or incidents.
Assist with the IDLB Proficiency Testing (PT) program to ensure compliance with state and federal regulatory requirements. Ensure that the IDLB 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.
Develop and maintain shared spreadsheets and databases for tracking Quality Assurance and Quality Control (QA/QC) for the IDLB.
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 IDLB 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 IDLB 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 research supervisors to discuss QA status. Function as the secondary contact for Genomics Center inquiries.
Ability to assist with other IDLB 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.
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
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 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, Crawl, Kneel, Bend - - - -Occasionally
Lift / Carry - - - - - - - - - - - - - - - -Occasionally - Up to 30 lbs
Push/Pull - - - - - - - - - - - - - - - - -Occasionally - Up to 50 lbs
See - - - - - - - - - - - - - - - - - - - - - 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.
Heluna Health is an Affirmative Action, Equal Opportunity Employer that encourages minorities, women, veterans, and disabled to apply.Equal Opportunity Employer/Protected Veterans/Individuals with DisabilitiesThe 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)

Keywords: Public Health Foundation Enterprises, In, Richmond , Quality Assurance Specialist, Other , Richmond, California

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