QA Specialist, Cell and gene therapy, Biologics

QA Specialist, Cell & Gene Therapy, BiologicsOur client, a medical device and biologics organization, has engaged GForce Life Sciences to provide a Cell & Gene Therapy QA Specialist. This position will support Quality activities for cell-line and biologics operations, working with the relevant Quality and scientific teams. The individual will perform hands-on cleanroom quality activities, incoming inspection and in-process controls, and help assess nonconformances and deviations. This is the more technically specialized of two onsite QA technician roles. The individual must understand cell and gene therapy processes well enough to evaluate whether processing and assay results remain within established limits or require formal deviation documentation. The role is hands-on and based at the Alameda site. The team operates in a fast-moving startup environment, so the consultant should be able to work from established procedures with limited day-to-day direction and adapt when priorities shift.Perform QA checks supporting cell-line and cell/gene therapy operations in cleanroom environments.Conduct incoming inspection and in-process quality controls.Review processing records and assay-related results against established procedures and acceptance criteria.Assess nonconformances and determine when issues remain within defined limits versus require deviation documentation and escalation.Support documentation accuracy, traceability, and related quality records.Experience: Approximately 3–4+ years in cell and gene therapy or closely related biologics Quality.Top skills: Cell/gene therapy process knowledge; cleanroom QA and incoming/in-process inspection.Experience with deviation/nonconformance assessment and quality documentation.Experience in a startup or similarly fast-paced environment with shifting priorities.Contract length: 3+ month contract with strong possibility of extensionStart ASAPFull-time, approximately 40 hours/week; hourly contractOnsite in Alameda, CA; hands-on floor presence requiredBenefits available (health, dental, vision, 401k)