Manager - QA Sterility Assurance

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The Manager for the QA Sterility Assurance group is an individual contributor responsible for quality oversight of the site contamination control strategy, including Environmental Monitoring (EM). 

Duties/Responsibilities include, but not limited to:

• Quality oversight and support for contamination control programs such as environmental monitoring, cleaning and disinfection, gowning, access and flow, facility modifications, qualifications, disruptions, and shutdowns. 
• Quality oversight and support for Microbiology QC Testing Methods.  Review and approve associated document revisions, protocols, reports, testing plans,
• Review and approve investigations/ CAPAs / effectiveness checks associated with the manufacturing site including but not limited to environmental monitoring excursions (EME), aseptic personnel qualification (APQ), aseptic operations, cleanrooms, utilities, and Microbiology laboratory.
• Quality Oversight and Management of Environmental Monitoring Trending Program.  Author or Review and approve EM and Utility trending reports at designated frequencies (i.e., quarterly, and annually). 
• Review and approve qualification lifecycle documentation associated with manufacturing cleanrooms, water and gas utilities, including but not limited to environmental monitoring process qualification (EMPQ), aseptic process simulation (APS), airflow visualization (AVS), cleanroom reclassification (CRC),
• Creation and Revision of technical documents (SOPs, Risk Assessments, Reports, Protocols, etc.).  Quality Approvals of documents created by others. 
• Quality oversight and approvals for disruptions and shutdowns to the cleanroom environment.
• Facilitate and/or approve quality risk assessments and technical reports associated with the contamination control strategy (CCS), including but not limited to disinfectant efficacy testing (DET), drug product process and facility microbial risk assessments).
• Review and approve or provide impact assessment for site change controls. Author impact assessments for complex level site change controls and EMPQ assessments. 
• Supports the Contamination Control Strategy, Quality Initiatives, and Identify continuous improvement opportunities.  Supports execution of site/team improvement goals and projects related to environmental and contamination control programs.   Perform associated quality approvals as required. 
• Routinely recognize and resolve Quality issues; propose solutions for complex issues and work with management to resolve.
• Support internal and external inspections as required. Participate in the preparation and execution of corrective and preventative actions related to inspection findings. Perform associated quality approvals as required.
• Maintain compliance with assigned learning plan. Support development of training content.
• Act as Subject Matter Expert and provide guidance/ coaching to less experienced staff with atypical microbial events.
• Lead meetings and represent function at cross functional and network meetings. Share data/ knowledge within team, and across site and network.
• Ability to collaborate with cross-functional team members on projects related to contamination control program. Build and maintain strong relationships with partner departments. 
• Perform other tasks as assigned. 

• This position reports to the Associate Director of Quality Assurance Sterility Assurance at Cell Therapy Manufacturing: Bothell.

Specific Knowledge, Skills, Abilities:

• Excellent verbal and technical writing skills with advanced ability to prepare written communications and present complex technical data to management with clarity and accuracy.