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Senior Specialist, QA Sterility Assurance
$92,290–$111,837 year
On-site · Bothell, Washington, United States
Job Summary
Senior Specialist, QA Sterility Assurance responsible for oversight and support of contamination control strategy (including NPI), approvals for Environmental Monitoring investigations, and support for CAPA creation and quality endorsement boards. Responsibilities include quality oversight for cleaning/disinfection, gowning, access/flow, facility modifications, qualifications, disruptions/shutdowns; review/approval of EM excursion investigations; creation/revision of SOPs and risk assessments; participate in site risk assessments; support contamination control programs, continuous improvement, and cross-functional collaboration; perform aseptic qualifications/observations, support environmental validations, and participate in internal inspections. Requires Bachelor’s degree in Microbiology/Biology/STEM or related science and 4+ years of cGMP experience; preferred experience with FDA/EMA regulation and biotechnology/cellular therapy; salary range $92,290–$111,837; Bothell, WA, US; on-site with potential hybrid site-design considerations per site policy.
Required Qualifications
- Bachelor's Degree in Microbiology, Biology, STEM, or related science
- 4+ years of relevant cGMP experience
- Experience in Quality Control Microbiology, Contamination Control, and Quality Assurance in a cGMP manufacturing operation
- Experience with FDA/EMA or similar regulation in biotechnology or cellular therapy is preferred
- Demonstrated cross-functional collaboration
- Experience with electronic systems and databases
- Root cause analysis and risk management tools (5-Why, Human Error Prevention, Fishbone Analysis, FMEA, PrHA)
- Ability to work across functional groups
- Knowledge of MS Office, Quickbase, Smartsheets; ability to learn new software
- Strong verbal and technical writing skills
- Advanced knowledge of cGMP manufacturing, Quality and Compliance
- Education/Experience: Bachelor's Degree; 4+ years of cGMP experience
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