Quality Assurance At-the-Source Specialist, Cell Therapy

AstraZeneca; Rockville (MD); On-site; USD 101,000 - 151,000; Full time

Benefits offered by this job

Short-term incentive bonuses

Health, dental, and vision coverage

Retirement programs

Job summary

AstraZeneca is seeking an independent Quality Assurance leader for cell therapy manufacturing. This shift-based role with a four-day Wednesday–Saturday schedule provides real-time QA guidance to ensure safe, compliant, and reliable operations across manufacturing areas.

The role requires strong cGMP knowledge, risk-based judgment, and the ability to coach cross-functional teams, leading to ready-for-inspection readiness and continuous improvement in a patient-focused environment.

Qualifications

• Bachelor's degree in Science, Engineering, Quality, or related field; GMP manufacturing experience.
• Ability to work independently in a regulated environment and apply cGMP principles.
• Strong risk-based judgment to distinguish routine issues from escalation.
• Proven ability to lead problem solving and communicate decisions clearly.

Responsibilities

• Maintain a consistent Quality presence in manufacturing areas and provide real-time guidance.
• Support manufacturing operations and resolve quality events in real-time.
• Assess routine and moderately complex quality situations and take appropriate action.
• Partner with cross-functional teams to clarify requirements and remove barriers.
• Lead problem solving and improvement activities with evidence-based decisions.
• Coach colleagues on quality thinking and data integrity.
• Contribute to operational meetings, shift handoffs, and readiness discussions.
• Manage multiple priorities with clear communication of risk and urgency.
• Support inspection readiness and represent Quality within delegated authority.
• Assist occasionally with off-hours or holidays for operations.

Skills

cGMP principles

Independent work in regulated env

Risk-based decision making

Problem-solving

Cross-functional collaboration

Communication

Gowning in controlled environments

Education

Bachelor's degree in Science, Engineering, Quality, or related field

Tools

Quality management systems

Digital manufacturing concepts

Job description

Job Profile Description

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. Specific quality-system responsibilities and approval authorities are defined through applicable procedures, qualifications, and delegated authority.

This is a shift-based role scheduled four days per week, Wednesday through Saturday.

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.
• The role may require additional responsibilities as necessary.

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 in accordance with 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 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.

The annual base pay for this position ranges from $100,880 - $151,321. Our positions offer eligibility for multiple incentives an opportunity to receive short-term incentive bonuses, equity-based awards for salaried roles and commissions for sales roles. Benefits offered include qualified retirement programs, paid time off (i.e., vacation, holiday, and leaves), as well as health, dental, and vision coverage in accordance with the terms of the applicable plans.

Date Posted 14-Oct-2026

Closing Date 27-Oct-2026

Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.