Microbiology QC Analyst IV - #1404732

The Microbiology IV will be responsible for the QC microbiological aspects of cGMP compliance and testing at the FUJIFILM Biotechnologies Diosynth Texas (FDBT) Quality Control Laboratory. This position is a pivotal role to either a technical career path as a Microbiologist IV or a managerial career path as a Lead for the team, and a successful individual in this role will lead the team regardless of the career path they decide to pursue.

Primary Responsibilities:

• Lead the QC microbiological aspects of cGMP compliance and testing.
• Write verification protocols and summary reports as needed for finished product and in process controls and buffers.
• Assist in performing environmental risk assessments for qualification of cleanrooms.
• Serve as SME for the functional streams: utility monitoring, environmental monitoring, and material monitoring.
• In charge of scheduling and managing the training and on-boarding of new staff members and be able to troubleshoot assays when there is a problem encountered.
• Assist in the identification of microbiological root cause analysis and provide technical advice as needed.
• Perform Cost Analysis for methods and monthly metrics of assays performed.
• Lead the investigations and review of alert and action limit investigations as needed and implements corrective action as appropriate.
• Manage the investigations of microbiological data deviations and PRs.
• Develop and/or contribute toward creating and revising microbiological Standard Operating Procedures (SOPs) and other current Good Manufacturing Practices (cGMP) documentation.
• Manage the weekly laboratory schedule of activities for the staff.
• Approval of EM and product release data.
• Manage the plan generation/scheduling in MODA-EM.
• Manage all equipment calibrations/PM events in Blue Mountain.
• Management of inventory for the laboratory and generation of Purchase Orders for supplies.
• Management of CAPAs, Change Controls and Deviations for the group.
• Ensure lab is maintained (organized, clean, properly supplied).
• Perform other duties as assigned.

Qualifications:

• Bachelor’s degree preferably in Biochemistry, Chemistry, Biology, or related field with 4+ years of relevant experience; OR
• Associate of Science preferably in Biochemistry, Chemistry, Biology, or related field with 5+ years of relevant experience; AND
• Proven experience at Level 4/Lead in managing commercial-scale operations and the ability to successfully uphold commercial operations.
• 2+ years in a GMP environment.
• Sound aseptic technique and understanding of industry best practices, techniques, equipment, and materials.
• Ability to analyze raw data, assess assay and system suitability criteria.
• Ability to follow safety procedures outlined in the Chemical Hygiene Plan.
• Utilize SDS sheets to properly assess chemical hazards, spill response procedures, and PPE requirements if indicated.
• Good attention to detail and ability to utilize problem solving/trouble shooting skills.
• Good computer skills.
• Demonstrated written and oral communication skills.
• Demonstrated leadership skills.
• Strong organization and analytical skills.
• Role model for company core values of trust, delighting our customers, Gemba, and Genki.

Join us! FDB is advancing tomorrow’s medicine, impassioning employees to chase the impossible and continually expand their potential. We are a company of emboldened goal seekers – driven by an innate desire to better ourselves, our families, our workplace, our company, our community and the world at large.