Associate II
Quality Assurance
Posted on 9/8/2023
Lyell Immunopharma

201-500 employees

Bothell, WA, USA
Experience Level
QA & Testing
  • Associate's or Bachelor's degree or an equivalent combination of education and work experience, preferably in a cell therapy environment
  • Fast learner, adaptable, with enterprise viewpoint and excellent cross-collaboration and inter-personal skills
  • The 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, meet deadlines and balance competing priorities
  • Excellent analytical skills and scientific/technical expertise
  • 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
  • Stand and step over a gowning bench (12-24”) and aseptically don head-to-toe non-sterile and sterile gowns
  • Collaborate with key stakeholders and system owners on the continuous improvement of the Quality GMP processes at LyFE
  • Implementation of GMP Quality Operations
  • Create and/or collaborate on corresponding SOPs
  • Represent Quality Assurance on project specific teams, as needed
  • Execute Routine Quality Assurance Operations
  • Perform review and approval of executed electronic batch records, and resolution of discrepancies with manufacturing personnel
  • Perform review and approval of Deviation and CAPA record deliverables
  • Provide quality support for manufacturing operations in the cleanroom facilities (e.g.,changeover/line clearance support, APH receipt, product pack-out, event triage)
  • Perform review and disposition of incoming raw materials, and approval of raw material specifications
  • Author and/or collaborate on the creation, revision, and obsoletion of Standard Operating Procedures across the LyFE site
  • Perform review and approval of asset induction/release deliverables, on-demand work, and non-conformances
  • Support other routine Quality operations as required, commensurate with experience and the LyFE site maturation
Desired Qualifications
  • 3+ years of cGMP experience in GMP biopharmaceutical operations and with prior experience in a GMP Quality role
  • Experience in clinical manufacturing
  • Experience with quality management systems (e.g. deviations, CAPAs, change management)