Quality Assurance Specialist

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 streamlin...