QC Analyst IV, Microbiology

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, Microbiolog

yWork Location College Station, T

X
Primary Responsibilitie

• s:Lead the QC microbiological aspects of cGMP compliance and testin
• g.Write verification protocols and summary reports as needed for finished product and in process controls and buffer
• s.Assist in performing environmental risk assessments for qualification of cleanroom
• s.Serve as SME for the functional streams: utility monitoring, environmental monitoring, and material monitorin
• g.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 encountere
• d.Assist in the identification of microbiological root cause analysis and provide technical advice as neede
• d.Perform Cost Analysis for methods and monthly metrics of assays performe
• d.Lead the investigations and review of alert and action limit investigations as needed and implements corrective action as appropriat
• e.Manage the investigations of microbiological data deviations and PR
• s.Develop and/or contribute toward creating and revising microbiological Standard Operating Procedures (SOPs) and other current Good Manufacturing Practices (cGMP) documentatio
• n.Manage the weekly laboratory schedule of activities for the staf
• f.Approval of EM and product release dat
• a.Manage the plan generation/scheduling in MODA-E
• M.Manage all equipment calibrations/PM events in Blue Mountai
• n.Management of inventory for the laboratory and generation of Purchase Orders for supplie
• s.Management of CAPAs, Change Controls and Deviations for the grou
• p.Ensure lab is maintained (organized, clean, properly supplied
• ).Perform other duties as assigne

d.Qualification

• s:Bachelor’s degree preferably in Biochemistry, Chemistry, Biology, or related field with 4 years of relevant experience;
• ORAssociate of Science preferably in Biochemistry, Chemistry, Biology, or related field with 5 years of relevant experience; A
• ND2 years in a GMP environmen
• t.Sound aseptic technique and understanding of industry best practices, techniques, equipment, and material
• s.Ability to analyze raw data, assess assay and system suitability criteri
• a.Ability to follow safety procedures outlined in the Chemical Hygiene Pla
• n.Utilize SDS sheets to properly assess chemical hazards, spill response procedures, and PPE requirements if indicate
• d.Good attention to detail and ability to utilize problem solving/trouble shooting skill
• s.Good computer skill
• s.Demonstrated written and oral communication skill
• s.Demonstrated leadership skill
• s.Strong organization and analytical skill