Associate 2, QC Microbiology

FUJIFILM Biotechnologies; Milwaukee (WI); On-site; USD 50,000 - 70,000; Full time

Job summary

A leading biopharmaceutical company is seeking an Associate 2 in QC Microbiology to perform microbiological testing and ensure compliance with CGMP standards. The ideal candidate will have relevant experience in microbiology, effective communication skills, and the ability to work in a collaborative environment. This role supports essential operations in a dynamic laboratory setting, contributing to innovative healthcare advancements.

Qualifications

• Knowledge of aseptic techniques and behaviors.
• Effective communication skills, both written and verbal.
• Ability to systematically approach daily tasks.

Responsibilities

• Perform microbiological testing per department SOPs.
• Ensure compliance with CGMP standards.
• Conduct environmental monitoring of controlled environments.

Skills

Knowledge of aseptic techniques

Effective communication

Technical writing

Problem-solving skills

Collaboration ability

Education

High School Diploma/GED with 6 years of Microbiology experience

Associate’s degree in Life Science or related field with 2-4 years of experience

Bachelor’s degree in Life Science or Biology with 1-2 years of experience

Tools

LIMS

TrackWise

Job description

Associate 2, QC Microbiology (Wednesday to Saturday 2pm - 12am)

The Associate 2, Quality Control (QC) Microbiology is responsible for performing routine microbiological testing of clean utility, environmental monitoring, and manufacturing batch samples. This role performs routine laboratory testing and support activities and actively participates in continuous improvement initiatives. 2nd shift.

Company Overview

At FUJIFILM Biotechnologies, we’re leading the charge in advancing tomorrow’s medicines. If you want to be a part of life-impacting projects alongside today’s most innovative biopharmaceutical companies, FUJIFILM Biotechnologies could be the right place for you. From our Bioprocess Innovation Center to our cGMP‑compliant manufacturing site, we thrive on collaboration, creativity, and purpose. Whether your expertise lies in research, manufacturing, or production, you’ll find a home here where your efforts directly improve patients’ lives. Together, let’s shape the future of healthcare. Situated at the cross-section of Morrisville and Research Triangle Park (RTP), North Carolina, our site is at the heart of a booming biotech hub surrounded by top universities, vibrant communities, and various outdoor opportunities. Fujifilm is globally headquartered in Tokyo with over 70,000 employees across four key business segments of healthcare, electronics, business innovation, and imaging. We are guided and united by our Group Purpose of “giving our world more smiles.”

Job Description

Major Accountabilities

• Provides facility support through the collection and testing of site clean utilities (e.g., water, steam, and compressed gases)
• Performs microbiological testing (e.g., Bioburden, Endotoxin, and Growth Promotion) per department Standard Operating Procedures (SOPs) and test methods for samples associated manufactured batches
• Reviews laboratory testing results and enters data into the Laboratory Information Management System (LIMS)
• Performs environmental monitoring of controlled manufacturing environments
• Ensures laboratory maintains inspection readiness, data integrity, and Current Good Manufacturing Practice (CGMP) compliance
• Assists management with technical services, such as initiating events (e.g., deviations and non-conformances) within quality systems
• Identifies and solves problems while consulting and under the direction of management
• Assists with laboratory equipment qualification and validation activities
• Participates in project developments from concept through execution, ensuring alignment with organizational goals. Performs other duties, as assigned

Knowledge, Skills or Abilities

• Knowledge of aseptic techniques and behaviors
• Effective communication, both written and verbal
• Technical writing and problem-solving skills
• Ability to complete work both independently and under guidance from Supervision
• Ability to systematically approach daily tasks
• Ability to effectively collaborate with coworkers and internal clients
• Knowledge of United States Pharmacopeia and European Pharmacopeia
• Ability to support audit readiness for the laboratory
• Willingness to incorporate lean lab and six sigma principles into the work environment
• Ability to manage and complete tasks according to a structured plan
• Knowledge and familiarity with data management systems (e.g., TrackWise, LIMS) and capability to learn basic use and navigation within the systems
• Must be flexible to support 24/7 manufacturing facility

Minimum Education and Experience Requirements

• High School Diploma/GED with 6 years of Microbiology experience; or
• Associate’s degree in Life Science, Pharmaceutical, or related field with 2-4 years of Microbiology experience; or
• Bachelor’s degree in Life Science or Biology with 1-2 years of Microbiology experience
• Experience with data management systems (e.g., LIMS, TrackWise)

Preferred Education and Experience Requirements

• 2+ years of CGMP laboratory experience

Physical Demands

• Ability to stand for prolonged periods of time 60 to 120 minutes
• Ability to sit for prolonged periods of time 60 to 120 minutes
• Ability to conduct activities using repetitive motions that include wrists, hands and/or fingers.
• Ability to operate machinery and/or power tools.
• Ability to conduct work that includes moving objects up to 10 pounds.
• Ability to bend, push or pull, reach to retrieve materials from 18” to 60” in height, and use twisting motions.

Environmental Conditions

• Will work in warm/cold environments. 2-8°C Range

EEO Information

Fujifilm is committed to providing equal opportunities in hiring, promotion and advancement, compensation, benefits, and training regardless of nationality, age, gender, sexual orientation or gender identity, race, ethnicity, religion, political creed, ideology, national or social origin, disability, veteran status, etc.

ADA Information

If you require reasonable accommodation in completing this application, interviewing, completing any pre‑employment testing, or otherwise participating in the employee selection process, please direct your inquiries to our HR Department ([e-mail]).