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Microbiology QC Manager

Scientific Search
Seattle, Washington, US
Closing date
Aug 10, 2021

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Consultancy/Private Sector
Conservation science
Salary Type
Employment Type
Full time
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QC Manager, MicrobiologyCheck out for all of our openingsThis 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. Responsibilities will also include in-process and drug substance sample testing and oversight in support of the GMP operations, laboratory staff training, GMP document authoring / revision and overseeing initiatives to build infrastructure and processes for the new Commercial manufacturing facility. The ideal candidate has a keen attention to detail, is highly organized in their work, has strong written and verbal communication skills, and works well independently and in teams.Responsibilities:Work with LIMS team to develop QC templates and workflows to support the Redmond Facility and Utilities systems qualificationSupport 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 SpecificationsParticipate in Quality Management ReviewsWork with team members to support the GMP QC Laboratory operations and build the infrastructure for a Commercial QC Microbiology laboratory Requirements: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 laboratoryAudit experience defending monitoring programs and investigationsExperience working with electronic systemsAttention to detail and highly organizedTechnical writing including analytical methods, technical summary reports and Standard Operating Procedures Preferred qualifications:Experience with Vitek Mass Spec instrumentationRelocation is provided for this role. Sponsorship not available

Please send resume to #LI-LB2Type: Direct HireCategory: CDMO
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