QA Operations Specialist (On-site) β Angleton, TX
MANDATORY: This is an on-site position based in Angleton, TX. Candidates must be within commutable distance.
Key Accountabilities
- Provide manufacturing quality oversight of production, quality control, and supply chain departments to ensure full cGMP adherence; escalate exceptions to management.
- Perform live review of manufacturing batch records in preparation for batch release; escalate exceptions immediately.
- Assist functional areas with timely and compliant final product dispositions.
- Ensure site personnel compliance, application of aseptic techniques, and adherence to sterile manufacturing regulations.
- Support FDA/Regulatory interactions for Angleton site activities and products (submissions and inspections).
- Support QA Operations as a business partner focused on safety, quality, delivery to patients, cost, compliance, and data integrity.
- Assist other departments with exception management and timely closure.
- Other related duties as assigned.
Education and Experience
- Bachelorβs degree in Life Sciences, Quality Management, or related field.
- 3+ years of experience in a quality assurance role.
- GxP manufacturing operations experience (preferred).
- Proper aseptic technique experience in controlled areas (preferred).
- Cross-functional collaboration; team communication with diverse groups.
- Willingness to work with radioactive materials and follow strict safety protocols.
Key Capabilities (role-relevant)
- Inclusive mindset, ethical behavior, adaptability, strong communication, collaboration, results-oriented drive, resilience, creativity/innovation, and continuous learning.