QA Operations Specialist

About This Role

The QA Operations Specialist manages quality-related activities and projects, ensuring GxP compliance and adherence to the Quality Management System at the Angleton, TX manufacturing site. This role supports the international roll-out of approved radiopharmaceutical products.

Responsibilities

• Provide manufacturing quality oversight for all production, quality control, and supply chain departments to ensure cGMP adherence
• Perform live review of manufacturing batch records in preparation for batch release and escalate exceptions
• Assist functional areas in achieving timely and compliant final product dispositions
• Ensure compliance of site personnel and application of aseptic techniques with sterile manufacturing regulations
• Support FDA/Regulatory interactions for Angleton site activities and products to ensure successful submissions and inspections
• Support QA Operations as a valued business partner, focusing on safety, quality, delivery, cost, compliance, and data integrity
• Assist other departments with exception management for compliance and timely closure of exceptions

Requirements

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

Qualifications

• Bachelors’ degree in Life Sciences, Quality Management, or related field
• 3+ years of experience in a quality assurance role.

Nice to Have

• Experience in GxP manufacturing operations
• Experience performing proper aseptic technique in controlled areas

Benefits