Senior Associate, Quality Assurance

Lyell Immunopharma•Bothell, WA

3d•Onsite

About The Position

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 individual will perform routine Quality Assurance tasks including but not limited to batch record review, raw material disposition, deviation investigation, CAPA, and change control approval, and other Quality Operations functions. This role requires working a Sunday through Wednesday shift, 10 hours per day, and is an onsite role with no remote work option.

Requirements

Experience in clinical and cGMP manufacturing required.
Experience with electronic quality management systems (e.g. deviations, CAPAs, change management) required.
Ability to work effectively both independently and with a team to set goals, develop sound project plans, monitor progress, and report results.
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
The desire and ability to work in a fast-paced, start-up
Excellent analytical skills and scientific/technical

Nice To Haves

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

Responsibilities

Review and approve executed electronic batch record comments and resolve discrepancies with manufacturing personnel.
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
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.
Compile, review and approve lot disposition records.
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.
Promote a culture of safety and GMP compliance.
Identify opportunities for continuous improvement.
Support Process and/or Method Qualification and Validation activities by providing quality review of associated protocols, data and reports.
Perform internal audits.
Support operational excellence initiatives.