See Yourself at Telix
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.
Key Accountabilities:
• 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 with exception management for compliance and timely closure of exceptions. • Other related duties as assigned.
Education and Experience:
Bachelors' degree in Life Sciences, Quality Management, or related field 3+ years of experience in quality assurance role Experience in GxP manufacturing operations is preferred Experience performing proper aseptic technique in controlled areas is preferred 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
Key Capabilities:
Inclusive mindset: Demonstrate an understanding and appreciation for diversity, and actively work to create an inclusive environment where everyone feels valued and respected
Creativity and innovation: Possess a willingness to think outside the box and come up with unique and creative solutions to challenges
Commitment to excellence: Take pride in your work and consistently strive for excellence in everything you do
Results-oriented: Driven to achieve goals and objectives, with a strong focus on delivering measurable results
Ethical behavior: Act with integrity and demonstrate a commitment to ethical behavior in all interactions with colleagues and stakeholders
Adaptability: Comfortable working in a dynamic environment, able to adjust to changing priorities, and willing to take on new challenges
Strong communication skills: Able to communicate effectively with colleagues and stakeholders at all levels, using clear and concise language
Collaboration: Work effectively as part of a team, actively sharing knowledge and expertise to achieve common goals
Resilience: Demonstrate the ability to bounce back from setbacks and persevere in the face of challenges
Continuous learning: Show a commitment to ongoing learning and professional development, continually seeking out opportunities to expand your knowledge and skills