Microbiology QC Manager
- Employer
- Society for Conservation Biology
- Location
- Seattle, Washington, US
- Salary
- Competitive
- Closing date
- Dec 13, 2022
View more
- Sector
- Nonprofit
- Field
- Conservation science
- Discipline
- Biology
- Salary Type
- Salary
- Employment Type
- Full time
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Location: Portland, OR areaCheck out www.scientificsearch.com for all of our openings.This individual will lead the Quality Control Microbiology group to support Facility and Water System Qualification activities for our new manufacturing facility in Redmond, WA. As a member of the QC Microbiology team, the successful candidate will have experience with LIMS implementation, as well as GMP laboratory experience specific to environmental monitoring and water system testing, reporting, and trending.
- Familiarity with the Vitek Mass Spec Microbial Identification system is a plus.
- Work with LIMS team to develop QC templates and workflows to support the Redmond Facility and Utilities systems qualification
- Support and oversee Qualification activities at the Redmond facility (Room classification and utilities)
- Perform QC Microbiology testing and method qualification in support of the GMP manufacturing schedule to include in-process and drug substance release (Bioburden, Endotoxin, and assay qualifications)
- Write and revise Environmental Monitoring and Water Reports, Quality Control Methods, Standard Operating Procedures (SOPs), and Material Specifications
- Participate in Quality Management Reviews
- Work with team members to support the GMP QC Laboratory operations and build the infrastructure for a Commercial QC Microbiology laboratory
- BS in Microbiology, Biology, Biochemistry or related field and 8 12 years of experience and a minimum of 5+ years of hands-on, industry experience managing a cGMP QC laboratory
- Audit experience defending monitoring programs and investigations
- Experience working with electronic systems
- Attention to detail and highly organized
- Technical writing including analytical methods, technical summary reports and Standard Operating Procedures
- Experience with Vitek Mass Spec instrumentation
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