Senior Laboratory Quality Technician

Cryoport Systems•Ball Ground, GA

35d

About The Position

The Senior Quality Laboratory Technician is responsible for overseeing daily laboratory operations, personnel, testing activities, equipment management, calibration programs, and laboratory compliance requirements. This position provides technical leadership and day-to-day technical direction and coordination for Laboratory Technicians, Senior Laboratory Technicians, and Manufacturing Quality Technicians while ensuring testing, inspection, and quality activities are conducted safely, accurately, efficiently, and in accordance with applicable procedures, quality system requirements, and regulatory standards. The Senior Quality Laboratory Technician serves as the primary technical and operational leader for laboratory functions and manufacturing quality support activities. The position requires technical competency equivalent to a Senior Laboratory Technician, along with demonstrated leadership experience in laboratory operations, quality systems, inspection activities, and personnel management.

Requirements

Associate degree in Engineering Technology, Physical Sciences, Life Sciences, Quality Assurance, or a related technical discipline required.
Minimum of 10 years of laboratory testing, quality, manufacturing, or related technical experience.
Minimum of 5 years of experience performing duties equivalent to a Senior Laboratory Technician.
Minimum of 3 years of experience serving as a technical lead, team lead, or in a senior laboratory leadership role coordinating laboratory operations and providing technical direction.
Experience and or exposure with GD&T.
Demonstrated experience supporting manufacturing operations, quality inspections, nonconformance investigations, and process improvement activities.
Demonstrated experience utilizing Keyence Coordinate Measuring Machine (CMM) systems, optical measurement equipment, precision metrology instruments, and applying GD&T principles to dimensional inspection and product acceptance.

Nice To Haves

Bachelor’s degree in Engineering, Science, Quality, or a related field.
Experience managing calibration systems and equipment control programs.
Experience working within a regulated environment such as ISO 9001/13485, FDA, GMP, GLP, or similar quality systems.
Experience with statistical analysis, test method validation, and process validation activities.
Experience supporting internal, customer, FDA, or notified body audits.

Responsibilities

Provide day-to-day technical direction and coordinate daily laboratory activities to ensure testing is completed accurately, efficiently, and on schedule.
Coordinate laboratory workload, priorities, staffing, and resource allocation.
Review test plans, protocols, procedures, and test results for technical accuracy and completeness.
Ensure laboratory equipment is maintained, calibrated, and available to support testing activities.
Ensure Quality Technicians are trained, qualified, and demonstrate competency in the operation and interpretation of results from the Keyence Coordinate Measuring Machine (CMM), optical measurement systems, and other dimensional inspection and metrology equipment used to support receiving, in-process, and final inspections.
Monitor laboratory performance metrics and implement improvements to increase efficiency and effectiveness.
Support troubleshooting of complex testing issues and equipment failures.
Coordinate laboratory scheduling and support cross-functional testing requirements.
Manage and maintain the calibration program for all laboratory, manufacturing, and engineering equipment.
Ensure calibration activities are performed in accordance with established schedules, procedures, and applicable standards.
Coordinate internal and external calibration services.
Maintain calibration records and ensure traceability to applicable standards.
Monitor calibration status and address overdue or out-of-tolerance conditions.
Support investigations and impact assessments associated with calibration discrepancies.
Ensure compliance with Quality Management System requirements related to equipment control and calibration.
Directly supervise Quality Technicians assigned to manufacturing operations.
Provide leadership, training, coaching, and technical support to Quality Technicians performing receiving, in-process, and final inspections.
Ensure Quality Technicians are properly trained, qualified, and capable of performing assigned inspection and testing activities.
Monitor quality inspection activities on the manufacturing floor to ensure compliance with established procedures, specifications, and quality requirements.
Support investigations involving nonconforming product, manufacturing quality issues, customer complaints, and corrective actions.
Partner with Manufacturing, Engineering, and Quality Assurance to identify and implement process improvements that enhance product quality and operational efficiency.
Review inspection data, quality metrics, and nonconformance trends to identify opportunities for improvement.
Ensure proper containment, segregation, disposition, and documentation of nonconforming product.
Provide technical guidance regarding product acceptance decisions, inspection methods, and quality requirements.
Promote a culture of quality, compliance, accountability, and continuous improvement throughout manufacturing operations.
Serve as the technical lead for Laboratory Technicians and Manufacturing Quality Technicians by providing day-to-day technical direction, work coordination, and operational support.
Provide technical guidance, coaching, mentoring, and training to laboratory and quality personnel, ensuring consistent application of laboratory methods, inspection techniques, and quality requirements.
Conduct employee onboarding and competency assessments and provide performance feedback to management.
Assist in recruiting, interviewing, and developing technical staff by providing technical evaluations and recommendations.
Support employee development through technical coaching, cross-training, competency development, and succession planning.
Promote a culture of safety, quality, accountability, teamwork, and continuous improvement.
Ensure compliance with applicable Quality Management System requirements, laboratory procedures, and regulatory standards.
Support internal audits, external audits, customer audits, and regulatory inspections.
Review and approve laboratory records, reports, and documentation.
Participate in nonconformance investigations, corrective actions, preventive actions, and continuous improvement initiatives.
Ensure proper documentation, retention, and integrity of laboratory records, inspection records, and test data.
Support maintenance and continuous improvement of quality system processes related to laboratory and manufacturing quality activities.
Provide advanced technical expertise in laboratory testing methodologies, equipment operation, inspection methods, and data analysis.
Support the development, validation, and improvement of test methods, inspection methods, protocols, and procedures.
Review test and inspection results and provide technical recommendations.
Lead investigations involving complex technical, quality, or manufacturing issues.
Serve as a subject matter expert supporting Engineering, Quality Assurance, Regulatory Affairs, and Manufacturing operations.
Ensure compliance with laboratory and manufacturing safety policies and procedures.
Conduct routine safety inspections and risk assessments.
Promote safe work practices and proper use of laboratory and inspection equipment.
Investigate and document safety incidents as required.