Quality Assurance Operations Specialist

Job Summary

Seeking a detail-oriented Quality Assurance Operations Specialist, the full-time position will manage quality aspects and projects, ensure GxP conformity, and support compliance with the Quality Management System at the Angleton manufacturing site.

Key responsibilities:

• Prepare, review, and maintain quality documents within the QMS, ensuring adherence to GMP policies
• Support internal and external audits, supplier quality activities, and assist in timely product dispositions
• Lead FDA/Regulatory interactions and collaborate with cross-functional teams on batch review and release activities

Required qualifications:

• Bachelor's degree in Life Sciences, Quality Management, or a related field
• 3+ years of experience in a quality assurance role, preferably in GxP sterile manufacturing operations
• Technical understanding of manufacturing, quality, and regulatory requirements
• Experience in writing and reviewing SOPs and specifications
• Willingness to work with radioactive materials and follow strict safety protocols