QA Operations Specialist

AMER • Angleton, TX

10h

About The Position

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 exception management for compliance and timely closure of exceptions. Other related duties as assigned.

Requirements

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

Nice To Haves

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

Responsibilities

• 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 exception management for compliance and timely closure of exceptions.
• Other related duties as assigned.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level