FUJIFILM Diosynth Biotechnologies · 1 day ago
QC Microbiologist IV (On-site in College Station, TX)
United States
Full-time
Remote
Mid, Senior Level
4+ years exp
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Hiring Manager
Lisa Cramer, MBA
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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.
Qualification
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Required
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
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.
Company
FUJIFILM Diosynth Biotechnologies
Fujifilm Diosynth Biotechn, contract development & manufacturing provider for preclinical, clinical and commercial biologics manufacturing.
1,001-5,000 employees
H1B Sponsorship
FUJIFILM Diosynth Biotechnologies has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2022 (1)
2021 (1)
Funding
Current Stage
Late StageLeadership Team
Morten Munk
Director - Global Alliance Management
S
Sharyn Farnsworth
Associate Principal Scientist
Recent News
Wake County Government (.gov)
2024-05-24
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