Senior Quality Control Associate

Do the best work of your life and enjoy it.

Quality Operations

Bothell, Washington, United States

03/20/25

This is a shifted, hourly position requiring on-site presence Wednesday-Saturday, from 12:00N
-10:30PM, with the potential for occasional overtime.

The candidate will support Quality Control (QC) operations at the Lyell Manufacturing Center (LyFE) in Bothell, WA. The scope of work includes in-process and release testing of cellular drug products, focusing on Flow Cytometry and Cell-Based Assay activities. Sample Management or Environmental Monitoring experience is a plus. The ideal candidate must be comfortable using electronic systems such as LIMS and Regulatory Asset Management Systems.

• Support routine QC Analytic activities, including in-process, stability, and release testing of raw materials, substances, and products.
• Support electronic Sample Management activities, including sample receipt, shipping, and delivery, and managing multiple stability programs and inventory control.
• Support routine QC Micro activities, including routine Environmental Monitoring of the GMP Facility.
• Perform equipment maintenance.
• Support QC Management in other routine Quality Control operations as required.
• Build strong communication and collaborative relationships across LyFE and the other Lyell sites.
• Demonstrate technical acumen, operational understanding, and GMP compliance.
• Support operational excellence initiatives.
• Promote a culture of safety and GMP compliance.
• Identify opportunities for continuous improvement.

• Bachelor’s degree or equivalent in biology, biochemistry, bioengineering, microbiology or related technological field or equivalent combination of education and experience, post-graduate coursework desirable

• Minimum 2‑3 years of experience in cell therapy GMP QC operations.
• Experience with electronic quality management systems (e.g. Master Control).
• Experience with electronic GMP operating systems (e.g., Labvantage, Labware, BMRAM, REES).

• 1‑3 years of experience in GMP Flow Cytometry and/or Cell-Based Assays
• Experience in Sample Management or Environmental Monitoring is a plus
• Experience collaborating and/or authoring GMP documents (Test Methods, Deviation Initiation, SOPs).

• Experience working in GMP manufacturing of drug substances and drug products.
• Fast learner, adaptable, with enterprise viewpoint and excellent cross‑collaboration and interpersonal skills.
• Can operate independently in the laboratory with minimal supervision.
• Strong communication skills to represent QC with the site cross‑functional teams.
• Strong technical writing skills.
• Desire and ability to work in a fast‑paced, start‑up environment.
• Motivated and organized critical thinker with solid interpersonal and business communication skills.
• Demonstrated ability to work effectively with a team to set goals, develop sound project plans, monitor progress, and report results.
• Ability to work efficiently, prioritize workflow, set and meet deadlines, and balance competing priorities.
• Intermediate analytical skills and scientific/technical expertise are expected.

• Confirm visual information in the environment such as batch record and SOP steps were completed properly, parameters on equipment and computer screens, status of materials and equipment, and perform visual inspection of materials and product. A vision test may be required. Use of corrective lenses is acceptable.

On‑site, Wednesday‑Saturday from 12

Noon
-10:30PM.

Due to the nature of autologous cell therapies and the need to deliver life‑saving treatments to our patients as timely as possible, shift work, weekend work, and holiday work will be required.

The salary range for this position is $34.62 - $38.46 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…