FUJIFILM Biotechnologies
Associate 1, Quality Control Microbiology
FUJIFILM Biotechnologies, Milwaukee, Wisconsin, United States, 53244
Associate 1, Quality Control Microbiology (Wednesday to Saturday 2pm to 12am)
Joining FUJIFILM Biotechnologies as an entry‑level QC microbiologist, you will conduct routine microbiological testing of clean utilities, environmental monitoring, and manufacturing batch samples, supporting continuous improvement initiatives and maintaining CGMP compliance.
Responsibilities
Collect and test site clean utilities (water, steam, compressed gases)
Perform basic microbiological tests (Bioburden, Endotoxin, Growth Promotion) per SOPs on batch‑associated samples
Review lab results and enter data into the Laboratory Information Management System (LIMS)
Conduct environmental monitoring of controlled manufacturing environments as needed
Ensure laboratory maintains inspection readiness, data integrity, and CGMP compliance
Assist management with technical services, including initiating deviations and non‑conformances within quality systems
Identify and solve problems under management direction
Participate in project development from concept through execution, aligning with organizational goals
Perform additional duties as assigned
Requirements
High School Diploma/GED with 4 years of microbiology experience, or
Associate’s degree in Life Science, Pharmaceutical, or related field with 2 years of microbiology experience, or
Bachelor’s degree in Life Science or Biology with no previous experience
Experience with data management systems (LIMS, TrackWise)
Knowledge of aseptic techniques and behaviors
Effective written and verbal communication
Basic technical writing and problem‑solving skills
Ability to work independently and under supervision
Systematic approach to daily tasks
Collaboration with coworkers and internal clients
Familiarity with USP and EP
Support audit readiness for the laboratory
Willingness to learn lean lab and Six Sigma principles
Structured task management
Preferred Experience
1–2 years of CGMP laboratory experience
Working Environment
Stand for 60–120 minutes, sit for 60–120 minutes
Perform repetitive wrist, hand, finger motions
Operate machinery or power tools
Move objects up to 10 lb
Bend, push, pull, reach to 18–60 in, use twisting motions
Environmental Conditions
Work in 2–8 °C temperature range
Seniority Level: Entry level | Employment Type: Full‑time | Job Function: Quality Assurance
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Responsibilities
Collect and test site clean utilities (water, steam, compressed gases)
Perform basic microbiological tests (Bioburden, Endotoxin, Growth Promotion) per SOPs on batch‑associated samples
Review lab results and enter data into the Laboratory Information Management System (LIMS)
Conduct environmental monitoring of controlled manufacturing environments as needed
Ensure laboratory maintains inspection readiness, data integrity, and CGMP compliance
Assist management with technical services, including initiating deviations and non‑conformances within quality systems
Identify and solve problems under management direction
Participate in project development from concept through execution, aligning with organizational goals
Perform additional duties as assigned
Requirements
High School Diploma/GED with 4 years of microbiology experience, or
Associate’s degree in Life Science, Pharmaceutical, or related field with 2 years of microbiology experience, or
Bachelor’s degree in Life Science or Biology with no previous experience
Experience with data management systems (LIMS, TrackWise)
Knowledge of aseptic techniques and behaviors
Effective written and verbal communication
Basic technical writing and problem‑solving skills
Ability to work independently and under supervision
Systematic approach to daily tasks
Collaboration with coworkers and internal clients
Familiarity with USP and EP
Support audit readiness for the laboratory
Willingness to learn lean lab and Six Sigma principles
Structured task management
Preferred Experience
1–2 years of CGMP laboratory experience
Working Environment
Stand for 60–120 minutes, sit for 60–120 minutes
Perform repetitive wrist, hand, finger motions
Operate machinery or power tools
Move objects up to 10 lb
Bend, push, pull, reach to 18–60 in, use twisting motions
Environmental Conditions
Work in 2–8 °C temperature range
Seniority Level: Entry level | Employment Type: Full‑time | Job Function: Quality Assurance
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