Quality Assurance At-the-Source Specialist, Cell Therapy

AstraZeneca•Rockville, MD

About The Position

Provides independent, visible Quality Assurance leadership at the source of cell therapy manufacturing. This shift-based role works four days per week, Wednesday through Saturday, partnering with Manufacturing and supporting functions to apply risk-based quality judgment, resolve issues within established frameworks, and support reliable, compliant execution. The specialist 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. Specific quality-system responsibilities and approval authorities are defined through applicable procedures, qualifications, and delegated authority. The role maintains a consistent Quality presence in manufacturing areas, provides real-time guidance, supports manufacturing unit operations, and assists with resolving manufacturing and quality events. It contributes to problem-solving, improvement activities, operational meetings, shift handoffs, readiness discussions, and inspection readiness. The role may require occasional off-hours or holiday support for manufacturing operations and patient commitments, as well as additional responsibilities as necessary.

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 under the approved job catalogue.
Demonstrated ability to work independently in a regulated environment and apply cGMP principles to real-time operational decisions.
Sound risk-based judgment, including distinguishing routine issues from those 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 additional scheduling requirements.

Nice To Haves

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.

Responsibilities

Maintain a consistent Quality presence in manufacturing areas and provide practical real-time guidance for safe, compliant, reliable execution.
Support manufacturing unit operations from a Quality Assurance perspective and assist with resolving manufacturing and quality events in real time.
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, 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.
Support inspection readiness and represent Quality within the scope of training, experience, and delegated authority.
Work a four-day-per-week Wednesday-through-Saturday shift and support occasional off-hours or holidays as needed.