Job Description

Duties:
The Quality Assurance team is seeking a highly motivated and detail-oriented Quality Assurance Senior Associate to join our team at the 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 either a Wednesday through Saturday shift or a Sunday through Wednesday shift, 10 hours per day, and is an onsite role with no remote work option.

• 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, Change Control, CAPA, Excursion and Nonconformance record deliverables (as applicable).
• Promote a culture of safety and GMP compliance.
• Identify opportunities for continuous improvement.
• Provide support to complex change controls (as applicable).
• Support Process and/or Method Qualification and Validation activities by providing quality review of associated protocols, data and reports.
• Perform internal audits (as applicable).
• Support operational excellence initiatives.

• 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 environment.
• Excellent analytical skills and scientific/technical expertise.

• 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.

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