Lyell Immunopharma

Specialist, Quality Assurance Validation

Bothell, Washington, United States

Sponsorship not specified$96k-$120kDetected 5 days ago

GMPCommunicationAdaptability

About the role

Maintain oversight of the qualified and validated state of Facility, Equipment, Utility, and computer systems through periodic review, requalification, deviation review, and change management.
Create and manage qualification and validation project schedules.
Support onboarding of new Facility, Equipment, and Utility assets by approving initial release requirements and defining quality expectations for lifecycle management.
The Quality Assurance Specialist provides QA oversight for Facility, Equipment, Utility (FEU), and Computer System (CS) programs in a cell therapy manufacturing environment, with accountability for review, approval, escalation, and lifecycle compliance activities that support GMP readiness and sustained operational control.

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the job.
While performing their duties, the employee must be able to do the following:

Prior experience in a Quality Assurance oversight role for Facility, Equipment, and Utility qualification and management.
Experience with computer system validation.
Previous experience using Blue Mountain computerized maintenance management software.
Experience with cell therapy and/or lentiviral manufacturing operations.
Experience in commercial manufacturing and post-approval lifecycle management.

Ability to work effectively both independently and cross-functionally.
Fast learner, adaptable, and has the desire and ability to work in a fast-paced, start-up environment.
Excellent communication, emotional intelligence and interpersonal skills.
Familiar with quality management systems (e.g. deviations, CAPAs, change management).
Curious and proactive mindset with a continuous improvement orientation.

The salary range for this position is $96,000 to $120,000, annually, with the opportunity to earn an annual bonus.

The salary range for this position is $96,000 to $120,000, annually, with the opportunity to earn an annual bonus.

We are committed to building an open, diverse and inclusive culture for all employees.

Lyell is proud to be an equal opportunity employer and does not discriminate on the basis of race, color, citizenship status, national origin, ancestry, sex, sexual orientation, age, religion, creed, physical or mental d

This listing is sourced directly from Lyell Immunopharma's careers page and normalized into a canonical job model.