The Role
Perform day-to-day GMP quality assurance tasks supporting manufacturing: review and approve electronic batch records, test results, COAs, raw material disposition, lot disposition, deviations, CAPAs, change control, and nonconformances. Provide cleanroom support, troubleshoot process escalations, perform internal audits, support validation/qualification, and promote continuous improvement and GMP compliance. Onsite role working a Sunday–Wednesday 10-hour shift.
Summary Generated by Built In
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.
KEY RESPONSIBILITIES:- Execute the Day-to-Day Quality Assurance Tasks to Support Ongoing Manufacturing:
- 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 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.
- 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 as required
- Support operational excellence initiatives.
PREFERRED EDUCATION:
- 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.
- 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 priorities
- The desire and ability to work in a fast-paced, start-up environment
- Excellent analytical skills and scientific/technical expertise
- This role requires working a Sunday through Wednesday shift, 10 hours per day, and is an onsite role with no remote work option.
The salary range for this position is $75,000 to $95,000 per year, 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.
At Lyell, we believe that highest performing teams include people from a wide variety of backgrounds and experiences who respectfully challenge each other. We are committed to building an open, diverse and inclusive culture for all employees. 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 disability, medical condition, marital status, veteran status or any other characteristics protected under applicable federal, state and local laws.
We’ve learned from experience that some of the best people don’t always match our requirements perfectly - if you’re interested and think you could fit, please don’t hesitate to apply.
Skills Required
- Experience in clinical and cGMP manufacturing
- Experience with electronic quality management systems (deviations, CAPAs, change management)
- Ability to perform review tasks in a Laboratory Information Management System (LIMS) and issue Certificates of Analysis (COAs)
- Ability to work onsite Sunday through Wednesday, 10-hour shifts (Bothell, WA)
- BS degree with 7+ years experience in biochemistry, chemical engineering, bioengineering, or related scientific field
- 4-6+ years experience in GMP biopharmaceutical operations with minimum 2+ years in GMP quality
- Proficiency using multiple digital GMP platforms
- Familiarity with Cellular Therapy manufacturing
- Familiarity with Lentiviral Vector manufacturing
- Strong communication, collaboration, organization, and problem-solving skills
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The Company
What We Do
We are entering a new era of medicine, where cancer is treated with cellular therapies: living, smart, targeted drugs. While enormous strides have been made, especially in hematologic cancers, the full promise of these therapies still lies ahead. Cell-based immunotherapies have yet to show substantial benefit in solid tumors, which represent the vast majority of cancers. Our goal is nothing less than to develop curative cell-based therapies for solid tumor cancers.
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