Source QA Lead — Cell Therapy, 4-Day Shifts

AstraZeneca; Rockville (MD); Sur place; USD 101 000 - 151 000; Plein temps

Avantages offerts par ce poste

Short-term incentive bonuses

Health, dental, and vision coverage

Retirement programs

Résumé du poste

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.

Responsabilités

• 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.

Connaissances

cGMP principles

Independent work in regulated env

Risk-based decision making

Problem-solving

Cross-functional collaboration

Communication

Gowning in controlled environments

Formation

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

Outils

Quality management systems

Digital manufacturing concepts

Description du poste

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.