Associate II, Quality Assurance

About the role

The Quality Assurance team is seeking a highly motivated and detail-oriented Quality Assurance Associate II to join our team at the Lyell Manufacturing Facility, LyFE in Bothell WA.

Responsibilities

• Perform review and approval of executed electronic batch records, and resolution of discrepancies with manufacturing personnel.
• Perform review and approval of Deviation, Excursion and CAPA record.
• Provide quality support for manufacturing operations in the cleanroom facilities (e.g. intake of incoming patient apheresis material, product pack-out, event triage).
• Be a quality point of contact for process support escalations, troubleshooting, triage and resolution.
• Review and disposition of incoming raw materials, and approval of raw material.
• Review and approve executed test results, perform review tasks in the laboratory information management system to issue Certificates of Analysis (COAs) as applicable.
• Author and/or collaborate on the creation, revision, and obsoletion of Standard Operating Procedures across the LyFE site.
• Review and approval of asset induction/release deliverables, on-demand work, and non-conformances.
• Support other routine Quality operations as required, commensurate with experience and the LyFE site maturation.
• Represent Quality Assurance on project specific teams, as needed.
• Promote a culture of safety and GMP compliance.
• Identify opportunities for continuous improvement.
• Perform internal audits as needed.
• Support operational excellence initiatives.

Qualifications

• Education: AA/BA or BSc degree or an equivalent combination of education and work experience.
• Experience: 3+ years of cGMP experience in GMP biopharmaceutical operations and with prior experience in a GMP Quality role.
• Skills: Proficiency using multiple digital GMP Platforms, Familiarity with Cellular Therapy manufacturing, Familiarity with Lentiviral Vector manufacturing.

Preferred Qualifications

• Experience: Clinical experience.
• Knowledge: Experience with electronic quality management systems (e.g. deviations, CAPAs, change management).
• Skills: Ability to work effectively both independently and with a team to set goals, develop sound project plans, monitor progress, and report results.
• Other: 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.

Benefits

This role requires working a shift schedule (either Sun-Wed or Wed-Sat), 10 hours per day, and is an onsite role with no remote work option.

Pay

The salary range for this position is $36.00 to $41.00 hourly, with the opportunity to earn an annual bonus. The salary range is an estimate, and the actual salary may vary based on Lyell’s compensation practices and an applicant’s qualifications and experience. Employees are also eligible to participate in Lyell’s Equity Incentive Plan.