Job Description

Purpose

Manages and provides strategic direction to team of individuals supporting Quality Control laboratory operations. Ensures effective and efficient utilization of laboratory resources through management of equipment and general laboratory support activities

Responsibilities

Manage a team and is responsible to hire, lead and develop team members to ensure that the department has the appropriate talent and level of performance to meet business objectives. Assure training and development of subordinates. Assist subordinates in problem solving. Identify and resolve people issues without direct supervision.

Assure conformance of equipment validation, calibration and maintenance procedures/requirements to all government and corporate regulations. Act as a subject matter expert for all customer and regulatory inspections for laboratory validation, calibration and maintenance program deliverables.

Manages internal and external service providers ensuring timely completion of activities in support of commissioning or maintenance/calibration of laboratory equipment.

Investigates equipment failures and identifies impact on product and patient safety. Applies systematic corrections and/or corrective actions that mitigate risk of recurrent failures

Manages general laboratory support responsibilities, including but not limited to; reagent preparation, sample management and sample logistics, lab consumable supply.