Job Information
FUJIFILM DIOSYNTH BIOTECHNOLOGIES Quality Control Analyst (QC Analyst) IV Microbiology in College Station, Texas
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QC Analyst IV, Microbiology
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Job LocationsUS-TX-College Station
Posted Date
7 days ago
(12/26/2024 12:31 PM)
Requisition ID : 2024-32455
Category : Quality Control
Company (Portal Searching) : FUJIFILM Diosynth Biotechnologies
Overview
The work we do at FDB has never been more importantand we are looking for talented candidates to join us. We are growing our locations, our capabilities, and our teams, and looking for passionate, mission-driven people like you who want to make a real difference in peoples lives. Join FDB and help create the next vaccine, cure, or gene therapy in partnership with some of the most innovative biopharma companies across the globe. We are proud to cultivate a culture that will fuel your passion, energy and drive - what FDB call Genki.
External US
College Station, Texas may be a small, university town, but the lively cultural scene and local amenities make it a great place for families as well as those who want the ease of small-town life and the convenience of living close to the vibrant pulse of big cities. Eighty-seven percent of Texas' population lives within a 180-mile radius, so we are in the center of it all in Texas. And our site is nestled in the hub of innovation, representing a source of pride for the area.
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.
Reports to
Supervisor, Microbiology
Work Location
College Station, TX
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.