QC Manager

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Job description

Just is seeking a highly motivated individual 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 join the Quality Control management team with an emphasis in Microbiology to support the completion of the Facility and Water Qualification activities for our new manufacturing facility in Redmond, WA. The ideal candidate will have Commercial GMP experience, will possess exceptional leadership skills and will be a mentor to our science-based team. The successful candidate will have experience with LIMS implementation, as well as GMP laboratory experience. Responsibilities will include in-process and drug substance sample testing, training of laboratory staff, GMP document authoring / revision, providing oversight in support of GMP operations and spearheading 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 and has strong written and verbal communication skills.

Responsibilities:

•Oversee the completion of the facility Qualification activities at the Redmond Facility

•Lead and provide guidance for QC Microbiology testing and method qualification in support of GMP Biologics manufacturing, including in-process and drug substance release testing by Bioburden and Endotoxin techniques

•Work with team members to support the GMP QC Laboratory operations and build the infrastructure for a Commercial QC Microbiology laboratory

•Lead a team of 4 individuals, mentor staff and promote career development opportunities

•Assure timely reporting and management of Environmental Monitoring and Water Reports, Quality Control Methods, Standard Operating Procedures (SOPs), and Material Specifications

•Participate in Quality Management Reviews

•Work with LIMS team to develop QC templates and workflows to support the Redmond Facility and Utilities systems qualification and other QC laboratory requirements

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 Analytical or Microbiology laboratory

•Expert understanding of ISO 14644 and USP/EU compendia methods

Audit experience

•Experience working with electronic systems

•Attention to detail and highly organized

•Proficient at technical writing including analytical methods, technical summary reports and Standard Operating Procedures

Middle Management