QA Operations Specialist - Angleton, TX (IsoTheraputics)

About the role

The QA Operations Specialist supports the international roll-out of Telix Pharmaceuticals' approved prostate cancer imaging agent and contributes to advancing the company's portfolio of late clinical-stage products addressing significant unmet needs in oncology and rare diseases.

Responsibilities

• Provide manufacturing quality oversight of all production, quality control, and supply chain departments to ensure adherence 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.
• Aid other departments in exception management for compliance and timely closure of exceptions.
• Other related duties as assigned.

Requirements

• Bachelor’s 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.

Qualifications

• Inclusive mindset: Demonstrates understanding and appreciation for diversity, creating an inclusive environment.
• Creativity and innovation: Willing to think outside the box and provide unique solutions to challenges.
• Commitment to excellence: Takes pride in work and strives for excellence.
• Results-oriented: Driven to achieve goals and objectives, focusing on measurable results.
• Ethical behavior: Acts with integrity and demonstrates commitment to ethical behavior.
• Adaptability: Comfortable working in a dynamic environment, adjusting to changing priorities, and taking on new challenges.
• Communication skills: Effective communicator with colleagues and stakeholders at all levels.
• Collaboration: Works effectively as part of a team, sharing knowledge and expertise.
• Resilience: Demonstrates ability to bounce back from setbacks and persevere in challenging situations.
• Continuous learning: Committed to ongoing learning and professional development.

Skills

• Quality Assurance
• Manufacturing Operations
• Regulatory Compliance
• Team Collaboration
• Radioactive Material Handling

Benefits

• Competitive Salaries
• Annual Performance-Based Bonuses
• Equity-Based Incentive Program
• Generous Vacation
• Paid Wellness Days
• Support for Learning and Development

Pay

Competitive salaries are offered, along with annual performance-based bonuses and an equity-based incentive program.

Schedule

Hybrid and remote work options are available, allowing flexibility in your work schedule.

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