Quality Assurance At-the-Source Specialist, Cell Therapy
AstraZeneca
Summary
Provides independent, visible Quality Assurance leadership at the source of cell therapy manufacturing. This is a shift-based role scheduled for four days per week, Wednesday through Saturday. Partners with Manufacturing and supporting functions to apply risk-based quality judgment, resolve issues within established frameworks, and support reliable, compliant execution. Operates independently across qualified routine and moderately complex situations, influences cross-functional decisions, and strengthens quality culture through practical coaching, clear communication, and disciplined follow-through.
Job description
Typical Accountabilities
- Maintain a consistent Quality presence in manufacturing areas and provide real-time, practical guidance that supports safe, compliant, and reliable execution.
- Support manufacturing unit operations from a Quality Assurance perspective and assist to resolve manufacturing events and/or quality events in real-time.
- Independently assess routine and moderately complex quality situations, integrate available facts and risk considerations, and determine appropriate action or escalation within established standards.
- Partner across functions to clarify requirements, align decisions, remove barriers, and sustain appropriate Quality independence.
- Recognize emerging risks, recurring issues, and performance gaps; communicate implications and recommend proportionate actions.
- Lead defined problem-solving and improvement activities, ensuring decisions are evidence-based, clearly documented, and carried through to effective resolution.
- Coach colleagues on quality thinking, disciplined execution, data integrity, contamination control, and right-first-time behaviors.
- Contribute quality judgment to operational meetings, shift handoffs, readiness discussions, and cross-functional decision forums.
- Manage multiple priorities independently, communicate changes in risk or urgency, and maintain reliable follow-through in a fast-paced patient-focused environment.
- Support inspection readiness and represent Quality confidently within the scope of training, experience, and delegated authority.
- Work a shift-based schedule of four days per week, Wednesday through Saturday, and support occasional off-hours or holidays as needed for manufacturing operations and patient commitments.
Qualifications and Skills
Essential
- Bachelor's degree in Science, Engineering, Quality, or a related technical field with relevant GMP quality or manufacturing experience; equivalent combinations of education and experience may be considered.
- Demonstrated ability to work independently in a regulated environment and apply cGMP principles to real-time operational decisions.
- Sound risk-based judgment, including the ability to distinguish routine issues from situations requiring broader escalation.
- Ability to lead defined problem-solving, synthesize facts, recommend actions, and communicate decisions clearly.
- Strong cross-functional collaboration and influencing skills, including respectful challenge and practical coaching.
- Ability to organize competing priorities and deliver high-quality work with limited day-to-day supervision.
- Ability to gown and work in controlled manufacturing environments.
- Ability to work the established four-day Wednesday-through-Saturday shift schedule and meet the additional scheduling requirements of the role.
Desirable
- Experience in biologics, aseptic processing, advanced therapies, or autologous cell therapy manufacturing.
- Working knowledge of international cell therapy GxP regulatory frameworks, regulations, and guidance.
- Experience with digital manufacturing, document management, learning, or quality systems.
Requirements
- Bachelor's degree in Science, Engineering, Quality, or a related technical field with relevant GMP quality or manufacturing experience; equivalent combinations of education and experience may be considered.
- Demonstrated ability to work independently in a regulated environment and apply cGMP principles to real-time operational decisions.
- Sound risk-based judgment, including the ability to distinguish routine issues from situations requiring broader escalation.
- Ability to lead defined problem-solving, synthesize facts, recommend actions, and communicate decisions clearly.
- Strong cross-functional collaboration and influencing skills, including respectful challenge and practical coaching.
- Ability to organize competing priorities and deliver high-quality work with limited day-to-day supervision.
- Ability to gown and work in controlled manufacturing environments.
- Ability to work the established four-day Wednesday-through-Saturday shift schedule and meet the additional scheduling requirements of the role.
- Experience in biologics, aseptic processing, advanced therapies, or autologous cell therapy manufacturing.
- Working knowledge of international cell therapy GxP regulatory frameworks, regulations, and guidance.
- Experience with digital manufacturing, document management, learning, or quality systems.
Benefits
- 401(k) Matching
- Paid Time Off
- Medical, Dental & Vision
- Short-term Incentive Bonuses
- Equity-based Awards
Company overview
AstraZeneca is a global, science-led, patient-focused pharmaceutical company dedicated to accelerating the delivery of life-changing medicines that create enduring value for patients, society, and shareholders. With a workforce of over 94,300 employees worldwide, the company operates across three core therapy areas: Oncology, BioPharmaceuticals (including Cardiovascular, Renal & Metabolism, Respiratory & Immunology), and Rare Disease. Headquartered in Cambridge, UK, AstraZeneca maintains strategic R&D centers in Cambridge, Gaithersburg (US), Boston (US), Gothenburg (Sweden), Shanghai, and Beijing. The company generated $54.1 billion in total revenue in 2024 and invested $13.6 billion in scientific research and development. AstraZeneca's bold aspiration is to be pioneers in science, lead in disease areas, and transform patient outcomes, with a goal to launch 20 new medicines and achieve $80 billion in total revenue by 2030. The company is recognized for its commitment to sustainability, health equity, and creating an inclusive work environment where diverse perspectives drive innovation.