Clinical Lab QA/QC Coordinator

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Position Summary

The Clinical Lab QA/QC Coordinator works at the direction of the Clinical Lab Manager to ensure that quality standards are consistently met and that all CAP/CLIA laws/regulations are strictly adhered to at all times. This position provides technical expertise to the laboratory staff as needed and facilitates communication between the Clinical Lab and any external governing entities. The QA/QC Coordinator is expected to hold regular periodic meetings with the management team to ensure that the Clinical Lab is always CAP/CLIA compliant and inspection ready at any moment. They will also support the Lab Accessioning & Safety Manager in providing guidance, monitoring and maintenance of all matters related to laboratory safety.

This is a full-time position that requires a minimum of 30 hours per week be spent on-site to provide proper support and ensure that the laboratory remains in full compliance at all times.

Essential Duties and Responsibilities

The essential functions include, but are not limited to the following:

• Review records related to the general operation and upkeep of a CLIA/CAP Quality Control laboratory, including but not limited to, QC test data, Quality Event (QE) documents, qualification documents, and validations.
• Receive, log, and release incoming supplies and material to the Quality Control laboratory.
• Support the maintenance of the document control system, including formatting, numbering, and scanning of records into the Document Management System (DMS).
• Support the maintenance of the Equipment Control and Service program, including but not limited to: the on-boarding of new equipment; maintaining calibration and preventative maintenance records; updating the equipment database; and notifying the laboratory of pending calibration/preventative maintenance activities.
• Support the maintenance of Deviation, Environmental Excursion, Investigations, and Change Control programs.
• Support the maintenance of the Internal and External Audit program, with guidance from Management.
• Track, analyze, and report on Quality Performance Indicators (QPIs).
• Participate in Internal Audits to ensure continued adherence to internal procedures and industry best practices.
• Responsible for editing and formatting SOPs, organizing documents, and helping the Clinical Lab to be inspection ready at all times.
• Stay current with changes to current CLIA/CAP and other relevant regulations.

Minimum Qualifications (Knowledge, Skills, and Abilities)

• Bachelor’s degree in a science related discipline.
• Minimum of two (2) years work experience in a CAP/CLIA laboratory.
• Someone who has previously held a CLS license is a bonus.
• Computer literacy and experience with Media Lab, Google Drive, Microsoft, DocuSign, PDFs, and other platforms related to file/document management.
• Excellent hand-eye coordination.
• Strong communications skills, both oral and written.
• Excellent analytical, organizational and time management skills.
• Ability to rapidly adapt to changing environments and circumstances.
• Ability to work effectively in a team environment.  
• Note: All offers of employment are contingent upon clear results of a thorough criminal background check.

Physical Demands and Work Environment

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the functions. While performing the duties of this position, the employee is regularly required to talk or hear. The employee frequently is required to use hands or fingers, handle, or feel objects, tools or controls. The employee is occasionally required to stand; walk; sit; reach with hands and arms; climb or balance; and stoop, kneel, crouch, or crawl. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this position include close vision, distance vision, color vision, peripheral vision, and the ability to adjust focus. The noise level in the work environment is usually moderate.

Job Type: FT Exempt

Shifts

‍Mon-Fri 9am-5:30pm with flexibility in scheduling.

Note: This is a full-time position that requires a minimum of 30 hours per week be spent on-site to provide proper support and ensure that the laboratory remains in full compliance at all times.

Compensation

Salary: $120-135K/year DOE

Benefits: Health, Vision, and Dental; 120 hours PTO; 401k