Quality Control Lead

 

See Yourself at Telix

The Quality Control Lead is a site-based role responsible for coordinating and performing Quality Control activities supporting clinical and commercial radiopharmaceutical production at the Wilkes-Barre facility. The role provides technical expertise in analytical method development and validation, specifications, stability programs, routine testing, laboratory investigations, equipment qualification, and GMP documentation.

During the facility’s build and validation phase, the Quality Control Lead will support the commissioning, qualification, validation, and operational readiness of the QC laboratory. Working under the direction of the Quality Director, Manufacturing Expansion & Readiness, the role will help implement the methods, procedures, equipment, documentation, and external laboratory support required to transition the facility into routine GMP operations.

Key Accountabilities:

Quality Control and Analytical Support

• Coordinate and perform analytical method development, validation, transfer, stability testing, and routine QC testing for clinical and commercial radiopharmaceutical products.
• Draft and maintain analytical methods, specifications, protocols, reports, and QC
• Review analytical data and laboratory records for accuracy, completeness, and compliance with cGMP

Laboratory Operations

• Coordinate laboratory equipment qualification, calibration, maintenance, and
• Maintain appropriate controls for laboratory materials, reagents, consumables, and reference
• Coordinate testing performed by external laboratories and review associated

Investigations and Compliance

• Lead or support assigned deviations, OOS/OOT investigations, CAPAs, change controls, and risk
• Ensure assigned QC activities comply with approved procedures, data-integrity standards, radiation-safety requirements, and applicable regulations.
• Support internal audits, external audits, regulatory inspections, and customer-complaint

Site Readiness and Improvement

• Support commissioning, qualification, validation, and operational readiness of the Wilkes-Barre QC
• Identify technical or compliance gaps and recommend improvements to analytical methods, equipment, documentation, and laboratory processes.
• Provide technical guidance and training to personnel and external partners supporting QC

Education and Experience:

• Bachelor’s degree in radiochemistry, chemistry, pharmacy, biochemistry, or a related scientific discipline required
• 5+ years’ experience in pharmaceutical or biotechnology Quality Control, analytical development, or Good Manufacturing Practices (GMP) laboratory operations
• Experience with analytical chemistry techniques, including chromatography and other relevant testing methods
• Experience with analytical method development, validation, verification, or
• Experience supporting stability programs, specifications, deviations, OOS/OOT investigations, CAPAs, and laboratory change controls.
• Working knowledge of pharmaceutical Quality Systems and applicable cGMP requirements, including 21 CFR Parts 210 and 211.
• Experience supporting facility or laboratory commissioning, qualification, validation, or operational readiness
• Experience coordinating work with contract laboratories or external testing providers
• Radiopharmaceutical, radiochemistry, or radioactive-material handling experience

Ability to provide technical guidance and coordinate activities without formal people-management authority.

Key Capabilities:

• 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
• Creativity and innovation: Possess a willingness to think outside the box and come up with unique and creative solutions to 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
• Inclusive mindset: Demonstrate an understanding and appreciation for diversity, and actively work to create an inclusive environment where everyone feels valued and respected
• Adaptability: Comfortable working in a dynamic environment, able to adjust to changing priorities, and willing to take on new challenges
• Ethical behavior: Act with integrity and demonstrate a commitment to ethical behavior in all interactions with colleagues and stakeholders
• Continuous learning: Show a commitment to ongoing learning and professional development, continually seeking out opportunities to expand your knowledge and skills