Senior Quality Assurance Associate
Lyell Immunopharma
6 months ago
On-site
Bothell, WA
Operations
Quality Assurance Senior Associate (Onsite)
KEY RESPONSIBILITIES:
- Execute day-to-day Quality Assurance tasks to support ongoing manufacturing
- Review and approve executed electronic batch record comments; resolve discrepancies with manufacturing personnel
- Review and approve executed test results; perform LIS review tasks to issue Certificates of Analysis (COAs) as applicable
- Provide quality support for manufacturing operations in the cleanroom
- Serve as a quality point of contact for process support escalations, troubleshooting, triage, and resolution
- Perform routine hands-on QA activities (e.g., intake of incoming patient apheresis; drug product pack-out activities)
- Compile, review, and approve lot disposition records
- Perform routine raw material disposition and approve raw material specifications
- Review and approve Deviation, Change Control, CAPA, Excursion, and Nonconformance deliverables (as applicable)
- Promote a culture of safety and GMP compliance
- Identify opportunities for continuous improvement
- Support process/method qualification and validation by providing quality review of protocols, data, and reports
- Perform internal audits; support operational excellence initiatives
PREFERRED EDUCATION:
- BS degree with 7+ years experience in a relevant field (e.g., biochemistry, chemical engineering, bioengineering, or related)
PREFERRED EXPERIENCE:
- 4–6+ years GMP biopharmaceutical operations; minimum 2+ years in GMP quality
- Proficiency using multiple digital GMP platforms
- Familiarity with Cellular Therapy manufacturing
- Familiarity with Lentiviral Vector manufacturing
KNOWLEDGE, SKILLS AND ABILITIES (REQUIRED):
- Experience in clinical and cGMP manufacturing
- Experience with electronic quality management systems (e.g., deviations, CAPAs, change management)
KNOWLEDGE, SKILLS AND ABILITIES (PREFERRED):
- Ability to work independently and with a team to set goals, develop project plans, monitor progress, and report results
- Excellent communication, emotional intelligence, and interpersonal skills
- Motivated, organized critical thinker with strong cross-collaboration and business communication skills
- Fast learner; adaptable; creative problem-solving
- Ability to prioritize, meet deadlines, and balance competing demands; desire to work in a fast-paced start-up
- Excellent analytical skills and scientific/technical ability
Schedule/Location:
- Sunday through Wednesday shift; 10 hours per day; onsite at Lyell Manufacturing Facility (LyFE), Bothell, WA; no remote work option
Benefits/Compensation:
- Salary range: $75,000 to $95,000 per year; opportunity for annual bonus; eligible for Lyell’s Equity Incentive Plan
Application Instructions:
- If you’re interested and think you could fit, please apply.
KEY RESPONSIBILITIES:
- Execute day-to-day Quality Assurance tasks to support ongoing manufacturing
- Review and approve executed electronic batch record comments; resolve discrepancies with manufacturing personnel
- Review and approve executed test results; perform LIS review tasks to issue Certificates of Analysis (COAs) as applicable
- Provide quality support for manufacturing operations in the cleanroom
- Serve as a quality point of contact for process support escalations, troubleshooting, triage, and resolution
- Perform routine hands-on QA activities (e.g., intake of incoming patient apheresis; drug product pack-out activities)
- Compile, review, and approve lot disposition records
- Perform routine raw material disposition and approve raw material specifications
- Review and approve Deviation, Change Control, CAPA, Excursion, and Nonconformance deliverables (as applicable)
- Promote a culture of safety and GMP compliance
- Identify opportunities for continuous improvement
- Support process/method qualification and validation by providing quality review of protocols, data, and reports
- Perform internal audits; support operational excellence initiatives
PREFERRED EDUCATION:
- BS degree with 7+ years experience in a relevant field (e.g., biochemistry, chemical engineering, bioengineering, or related)
PREFERRED EXPERIENCE:
- 4–6+ years GMP biopharmaceutical operations; minimum 2+ years in GMP quality
- Proficiency using multiple digital GMP platforms
- Familiarity with Cellular Therapy manufacturing
- Familiarity with Lentiviral Vector manufacturing
KNOWLEDGE, SKILLS AND ABILITIES (REQUIRED):
- Experience in clinical and cGMP manufacturing
- Experience with electronic quality management systems (e.g., deviations, CAPAs, change management)
KNOWLEDGE, SKILLS AND ABILITIES (PREFERRED):
- Ability to work independently and with a team to set goals, develop project plans, monitor progress, and report results
- Excellent communication, emotional intelligence, and interpersonal skills
- Motivated, organized critical thinker with strong cross-collaboration and business communication skills
- Fast learner; adaptable; creative problem-solving
- Ability to prioritize, meet deadlines, and balance competing demands; desire to work in a fast-paced start-up
- Excellent analytical skills and scientific/technical ability
Schedule/Location:
- Sunday through Wednesday shift; 10 hours per day; onsite at Lyell Manufacturing Facility (LyFE), Bothell, WA; no remote work option
Benefits/Compensation:
- Salary range: $75,000 to $95,000 per year; opportunity for annual bonus; eligible for Lyell’s Equity Incentive Plan
Application Instructions:
- If you’re interested and think you could fit, please apply.