Manager, Quality Control - Clinical Lab

Ambry Genetics Corporation; Aliso Viejo (CA); On-site; USD 120,000 - 155,000; Full time

Job summary

Ambry Genetics Corporation is seeking a highly motivated Manager of Quality Control for the Clinical Lab. Lead the QC department, ensure regulatory compliance, and drive continuous improvement across QC processes and SOPs.

This role will work closely with Clinical Lab Operations to maintain quality standards and regulatory adherence. The Manager will oversee staff, equipment, and documentation, participate in audits, perform risk assessments, and coordinate with QA and Automation teams to ensure

Qualifications

• Experience leading a Quality Control department in a clinical lab.
• Strong knowledge of quality systems, SOPs, and regulatory inspections.
• Ability to perform quality/risk assessments and participate in audits.

Responsibilities

• Manage the Quality Control department and staff.
• Define resource needs, performance metrics, and staff development plans.
• Own QC SOPs and ensure training on procedures/regulations.
• Oversee reagent inventory, QC testing, and transfer of qualified materials.
• Support QA with audits/inspections and risk assessments.
• Coordinate with Automation team on equipment and PM logs.

Skills

QC management

Regulatory compliance

SOP development

Staff coaching

QA collaboration

Quality metrics

Education

Licensure CLS/CGMBS

Job description

## Manager, Quality Control - Clinical LabApply: Ambry Lab: Full time: Posted 30+ Days Ago: JR202600447**Compensation:**$120,000 - $155,000 base salaryA 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.**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.