Quality Lab Supervisor

Flex

10d

About The Position

To support our extraordinary teams who build great products and contribute to our growth, we’re looking to add a Quality Lab Supervisor located in Austin, TX. Reporting to the Quality Manager, the Quality Lab Supervisor role will lead and coordinate process confirmation testing activities in a GMP, FDA 21 CFR Part 820 & ISO-regulated laboratory environment. This role acts as the Subject Matter Expert (SME) for PCT lab operations and serves as the primary point of contact during the assigned shift, ensuring accurate, compliant, and timely laboratory execution.

Requirements

Bachelor’s degree or equivalent experience.
3+ years of laboratory supervisory experience, preferably in medical or regulated environments.
Strong background in GMP, quality systems, and laboratory operations.
Proven ability to lead teams, drive investigations, and manage priorities in a fast-paced environment.

Responsibilities

Supervise and coordinate daily PCT lab operations, including scheduling and execution of testing activities.
Serve as the main point of contact and SME for PCT lab processes, equipment, and methods.
Review, verify, and approve test data and DHR documentation to support product disposition.
Lead OOS/OOT investigations, CAPAs, and ensure timely completion of corrective actions.
Ensure laboratory equipment, methods, and environments meet GMP, FDA, ISO, and customer standards.
Maintain audit readiness and support internal, external, and customer audits.
Coach, train, and mentor laboratory staff; ensure training requirements are completed and documented.
Support process improvements, change control, and validation activities (IQ/OQ/PQ).
Collaborate with Quality, Engineering, and Program teams on customer-related quality topics.
Promote a strong Safety First, compliant, and efficient lab culture.