Senior Quality Assurance Associate

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 #J-18808-Ljbffr Scorpion Therapeutics