FUJIFILM Biotechnologies

QC Associate 1, Environmental Monitoring (Wednesday - Saturday 10am - 8pm)

FUJIFILM Biotechnologies, Milwaukee

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The Associate 1, Quality Control (QC) Environmental Monitoring (EM) is an entry level position responsible for performing site environmental and clean utility monitoring within the manufacturing classified areas. This role performs routine laboratory testing and support activities in continuous improvement initiatives.
Company Overview
At FUJIFILM Biotechnologies, were leading the charge in advancing tomorrows medicines. If you want to be a part of life-impacting projects alongside todays 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, youll find a home here where your efforts directly improve patients lives. Together, lets 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. Visit:
Job Description
Major Accountabilities

Supports manufacturing operations through routine EM of classified production areas
Provides facility support through the collection and testing of site clean utilities (e.g., water, steam, and compressed gases)
Performs basic microbiological testing per department standing operating procedures (SOPs) and test methods for samples associated with Environmental and Clean Utility Monitoring
Performs subculturing and Gram staining of recovered microbiological isolates
Reviews laboratory testing results and enters data into the Laboratory Information Management System (LIMS)
Ensures laboratory maintains inspection readiness, data integrity, and Current Good Manufacturing Practice (CGMP) compliance
Operates facility and laboratory autoclaves
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
Participates in project developments from concept through execution, ensuring alignment with organizational goals.
Performs other duties, as assigned.

Knowledge, Skills Or Abilities

Ability to aseptically gown into classified manufacturing spaces
Knowledge of aseptic techniques and behaviors, and working within ISO 8 and ISO 7 environments
Effective communication, both written and verbal
Basic 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
Familiarity with United States Pharmacopeia and European Pharmacopeia
Ability to support audit readiness for the laboratory
Willingness to learn and incorporate lean lab and six sigma principles into the work environment
Ability to manage and complete tasks according to a structured plan
Basic understanding and familiarity with data management systems, such as 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 4 years of Microbiology experience; or
Associates degree in Life Science, Pharmaceutical, or related field with 2 years of Microbiology experience; or
Bachelors degree in Life Science or Biology with no previous experience
Experience with data management systems (e.g., LIMS, TrackWise)

Experience Requirements

1-2 years of CGMP laboratory experience

PHYSICAL DEMANDS
Will work in environment which may necessitate respiratory protection. No X Yes
May work in Mechanical/Production spaces that may require hearing protection and enrollment in a hearing conservation program. X No Yes
Will work in environment operating a motor vehicle or Powered Industrial Truck. X No Yes
Ability to discern audible cues. X No Yes
Ability to inspect or perform a task with 20/20 corrected vision, visual acuity, including distinguishing color. X No Yes
Ability to ascend or descend ladders, scaffolding, ramps, etc. X No Yes
Ability to stand for prolonged periods of time. No X Yes 60-120 minutes (If yes, may specify frequency/duration: up to 15, 30, 120, 240 minutes)
Ability to sit for prolonged periods of time. No X Yes 60-120 minutes (If yes, may specify frequency/duration: up to 15, 30, 120, 240 minutes)
Ability to conduct activities using repetitive motions that include wrists, hands and/or fingers. No X Yes
Ability to operate machinery and/or power tools. No X Yes
Ability to conduct work that includes moving objects up to X pounds. No X Yes If yes, X 10 lbs. 33 lbs.
Ability to bend, push or pull, reach to retrieve materials from 18 to 60 in height, and use twisting motions. No X Yes
ENVIRONMENTAL CONDITIONS
Will work in warm/cold environments. No X Yes 2-8 C Range (If yes, specify approximate temperature ranges.)
Will work in outdoor elements such as precipitation and wind. X No Yes
Will work in small and/or enclosed spaces. X No Yes
Will work in heights greater than 4 feet. X No Yes
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 ( ).

Seniority level

Seniority level
Entry level

Employment type

Employment type
Full-time

Job function

Job function
Research, Analyst, and Information Technology

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