QC Manager, Microbiology 

Redmond, WA
Oct 04, 2021
Required Education
Bachelors Degree
Position Type
Full time

Just is seeking a highly motivated Scientist who desires a significant opportunity to improve worldwide access to biotherapeutics. We are looking for someone to join a fast paced, collaborative, and multidisciplinary team. 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. 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.

•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

Preferred qualifications:
•Experience with Vitek Mass Spec instrumentation

Middle Management