Lyell Immunopharma

Senior Associate, Quality Assurance

Bothell, Washington, United States · Senior

Sponsorship not specified$75k-$95kDetected 6 days ago

GMPCommunicationCollaborationProblem SolvingAdaptability

About the role

The Quality Assurance team is seeking a highly motivated and detail-oriented Quality Assurance Senior Associate to join our team at the Lyell Manufacturing Facility, LyFE in Bothell WA.
This role requires working a Sunday through Wednesday shift, 10 hours per day, and is an onsite role with no remote work option.
Employees are also eligible to participate in Lyell's Equity Incentive Plan.

Execute the Day-to-Day Quality Assurance Tasks to Support Ongoing Manufacturing:
Review and approve executed test results, perform review tasks in the laboratory information management system to issue Certificates of Analysis (COAs) as applicable.
Provide quality support for manufacturing operations in the cleanroom facilities
Be a quality point of contact for process support escalations, troubleshooting, triage and resolution.
Perform routine hands-on QA activities such as intake of incoming patient apheresis and drug product pack-out activities.
Perform routine raw material disposition and approve raw material specifications.
Perform review and approval of Deviation, Chage Control, CAPA, Excursion and Nonconformance record deliverables, as applicable.
Support Process and/or Method Qualification and Validation activities by providing quality review of associated protocols, data and reports.
Support operational excellence initiatives.
Ability to work effectively both independently and with a team to set goals, develop sound project plans, monitor progress, and report results.

BS degree with 7+ years experience in a relevant field (e.g. biochemistry, chemical engineering, bioengineering, or related scientific field)
4-6+ years of experience in GMP biopharmaceutical operations with a minimum of 2+ years in GMP quality
Proficiency using multiple digital GMP Platforms
Familiarity with Cellular Therapy manufacturing
Familiarity with Lentiviral Vector manufacturing

Experience in clinical and cGMP manufacturing required.
Experience with electronic quality management systems (e.g. deviations, CAPAs, change management) required.
Excellent communication, emotional intelligence and interpersonal skills.
Motivated and organized critical thinker with solid cross-collaboration and business communication skills.
Fast learner, adaptable, with creative problem-solving skills.
Ability to work efficiently, prioritize workflow, meet deadlines and balance competing priorities
The desire and ability to work in a fast-paced, start-up environment
Excellent analytical skills and scientific/technical expertise

The salary range for this position is $75,000 to $95,000 per year, with the opportunity to earn an annual bonus.

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.