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Quality Assurance Operations Specialist

On-site Full-time

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Experience Level

Experience

Qualifications

Education and Experience:Bachelor's degree in Life Sciences, Quality Management, or a related field. A minimum of 3 years of experience in a quality assurance role. Preferred experience in GxP manufacturing operations. Experience with proper aseptic techniques in controlled environments is preferred. Ability to collaborate across functional teams is essential. Willingness to work in a dynamic environment.

About the job

At Telix Pharmaceuticals, we are a leading and rapidly expanding radiopharmaceutical company, with our headquarters in Australia and additional offices in Belgium, Japan, Switzerland, and the United States. Our mission is to fulfill the promise of precision medicine through targeted radiation therapies. We are dedicated to developing innovative products that enhance the lives of individuals battling cancer and rare diseases. As a crucial member of our team, you will play a vital role in the global launch of our prostate cancer imaging agent and contribute to advancing our portfolio of late-stage clinical products aimed at addressing urgent needs in oncology and rare diseases.

Join Us at Telix

The Quality Assurance Operations Specialist will oversee quality-related initiatives and projects in their designated area, ensuring compliance with GxP standards and adherence to the IsoTherapeutics Quality Management System at our Angleton, TX manufacturing facility.

Key Responsibilities:

  • Oversee quality assurance within all manufacturing, quality control, and supply chain operations to ensure strict compliance with current Good Manufacturing Practices (cGMP). Promptly escalate any deviations to management.
  • Conduct live reviews of manufacturing batch records in preparation for batch releases, immediately addressing any discrepancies.
  • Collaborate with various teams to ensure timely and compliant final product dispositions for manufactured products.
  • Ensure site personnel adhere to aseptic techniques and comply fully with sterile manufacturing regulations.
  • Support FDA and regulatory interactions concerning Angleton site activities and products, facilitating successful regulatory submissions and inspections.
  • Act as a trusted partner in QA Operations, fostering a culture of safety, quality, and integrity in data and compliance.
  • Assist in managing compliance-related exceptions across departments, ensuring timely resolutions.
  • Perform additional related tasks as assigned.

About Telix Pharmaceuticals

Telix Pharmaceuticals is at the forefront of radiopharmaceutical innovation, dedicated to improving patient outcomes through precision medicine. Our global presence emphasizes our commitment to addressing critical healthcare needs in oncology and rare diseases.

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