QA Operations Specialist

Telix Pharmaceuticals (AMER)•Angleton, TX

About The Position

The QA Operations Specialist is responsible for managing quality‑related activities and projects within their assigned area, supporting overall GxP compliance, and maintaining adherence to the IsoTherapeutics Quality Management System at the Angleton, TX manufacturing site.

Requirements

Bachelors’ degree in Life Sciences, Quality Management, or related field
3+ years of experience in quality assurance role.
Cross functional collaboration is a requirement for the position
Ability to work in a team environment and communicate effectively with diverse groups.
Willingness to work with radioactive materials and follow strict safety protocols.

Nice To Haves

Experience in GxP manufacturing operations is preferred
Experience performing proper aseptic technique in controlled areas is preferred.

Responsibilities

Provide manufacturing quality oversight of all production, quality control, and supply chain departments to ensure the practice fully adheres to cGMP. Ensure timely escalation to management of all exceptions.
Perform live review of manufacturing batch records in preparation for batch release and escalate any exceptions immediately.
Assist functional areas with achieving timely and compliant final product dispositions of the product being manufactured.
Ensure compliance of site personnel and application of aseptic techniques and full compliance with sterile manufacturing regulations.
Support FDA/Regulatory interactions for the Angleton site activities and products to ensure successful regulatory submissions and inspections.
Support QA Operations as a valued business partner, with a culture of safety, quality, delivery to patients, cost, compliance and data integrity.
Assist other departments exception management for compliance and timely closure of exceptions.
Other related duties as assigned.