Quality Control Specialist

About the role

The QC Specialist will support the international roll-out of Telix's approved prostate cancer imaging agent and contribute to advancing the company's portfolio of late clinical-stage products addressing significant unmet needs in oncology and rare diseases.

Responsibilities

• Execute lab operations to ensure compliance with GMP principles, data integrity, and good lab practices as applicable.
• Timely escalate all quality events and investigations to management.
• Lab activities cover QC testing on radioactive material. Experience in specific QC techniques such as HPLC, GC, TLC or ELISA is preferred.
• Continuously identify areas of improvement for the lab and testing processes.
• Independently complete all routine documentation in compliance with GDP.
• Perform method validation activities including method development and qualification.
• Review QC testing data for accuracy to support batch release process (including mAbs and small molecules).
• Participate in and perform laboratory investigations (OOS), deviations, change control, and implement corrective/preventive actions.
• Manage QC material (consumables and chemicals) and laboratory equipment (maintenance, calibration, qualification, requalification, installation).
• Write and update Quality Control procedures.
• Ensure compliance of site personnel and apply aseptic techniques and GMP principles.
• Support FDA/Regulatory interactions for Angleton site activities and products to ensure successful regulatory submissions and inspections.
• Aid QA and other departments with investigations and timely closure of investigations.
• Understand and adhere to GMP policies and procedures.

Requirements

• Minimum of a Bachelor’s degree in chemistry, biochemistry, biology, or related field.
• 3+ years of experience in a laboratory role within a GMP environment.
• Experience in GxP manufacturing operations is preferred.
• Experience performing proper aseptic technique in controlled areas is preferred.
• Excellent cross-functional collaboration skills.
• Effective communication and teamwork abilities.
• Ability to work with radioactive materials and follow strict safety protocols.

Qualifications

• Inclusive mindset: Demonstrates understanding and appreciation for diversity and works towards creating an inclusive environment.
• Creativity and innovation: Willing to think outside the box and come up with 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 a commitment to ethical behavior.
• Adaptability: Comfortable working in a dynamic environment, adjusting to changing priorities, and taking on new challenges.
• Strong communication skills: Communicates effectively with colleagues and stakeholders at all levels, using clear and concise language.
• Collaboration: Works effectively as part of a team, sharing knowledge and expertise to achieve common goals.
• Resilience: Demonstrates the ability to bounce back from setbacks and persevere in the face of challenges.
• Continuous learning: Shows a commitment to ongoing learning and professional development, seeking out opportunities to expand knowledge and skills.

Skills

• Knowledge of GMP, GLP, and GDP principles.
• Experience with HPLC, GC, TLC, or ELISA.
• Good laboratory practices and data integrity.
• Experience with aseptic techniques and GMP principles.
• Ability to work independently and manage multiple tasks.
• Strong problem-solving and critical thinking skills.
• Excellent organizational and time management skills.

Benefits

• Competitive salaries.
• Annual performance-based bonuses.
• An equity-based incentive program.
• Generous vacation and paid wellness days.
• Support for learning and development.

Pay

Competitive salary based on qualifications and experience.

Schedule

Hybrid and remote work options available.