Manager, Quality Control - Clinical Lab

Ambry Genetics

2d•$120,000 - $155,000•Onsite

About The Position

A highly motivated and team-oriented Manager of Quality Control. Responsible for ensuring that the Clinical Laboratory operates within established processes to ensure the product meets or exceeds all quality standards set forth in regulatory, client, and company requirements. This role will work closely with Clinical Lab Operations to ensure compliance is met or exceeded across all Clinical Laboratory teams. If you possess the appropriate licensure CLS/CGMBS/etc., you may be asked to perform operational tasks as part of your duties. This role will have direct reports so previous management experience is preferable.

Requirements

Appropriate licensure CLS/CGMBS/etc.
Previous management experience is preferable.

Responsibilities

Manage the Quality Control department.
Responsible for delegation of duties, scheduling, performing employee one on one meetings, providing staff with feedback and performance appraisals of all QC staff.
Responsible for developing detailed action plans, defining resource requirements, defining performance measurements, and aligning staff with the overall Quality Control objectives.
Document owner for quality control related SOPs.
Conduct and ensure training is completed for new and existing staff members on new quality procedures and regulations as they are updated.
Responsible for the management of reagent inventory, preparation and documentation of quality control testing, and transfer of the qualified materials into the laboratory.
Support QA department with audits and inspections.
Perform quality/risk assessments for quality control aspects of the laboratory testing process.
Perform annual health and safety risk assessments.
Ensure completion of quality control activities, including but not limited to proficiency testing, comparability of results, and reagent qualification.
Develop and maintain quality control systems for the clinical laboratory.
Manages incoming equipment in conjunction with Automation Team.
Manages PM log creation; IQ/OQ forms; asset allocation.
Manages organization and monitoring of equipment maintenance, IQ/OQ’s, repairs and owner’s manuals in conjunction with Automation team.
Manages and schedules third party vendor service visits to address equipment issues in conjunction with Automation team.
Responsible for all daily room temperature/humidity and equipment temperature checks.
Responsible for the organization and archiving of QC records.
Responsible for providing feedback for continuous improvement of Quality Control processes and for future feature requests/additions into quality control systems.
Collaborate with cross-functional teams who impact quality control testing in the laboratory.