QC Associate I, Environmental Monitoring

Fujifilm•Research Triangle Park, NC

1d•Onsite

About The Position

The QC Associate I role in Quality Control Microbiology is crucial for performing operational functions of the QC Microbiology laboratory. This position holds the responsibility for conducting environmental and clean utility monitoring and standard microbiological assays. The incumbent will operate under guidance of laboratory supervisors and lead analysts, ensuring technical issues are promptly escalated to laboratory management. Tasks will be assigned to off-shift personnel where possible. Overtime and temporary shift changes will be required to support programs that have samples with short testing windows (e.g., bioburden 12-hours). 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.” Visit: https://www.fujifilm.com/us/en/about/region/careers

Requirements

Strong working knowledge of aseptic techniques and behaviors
Effective communication, both written and verbal
Technical writing and problem-solving skills
Ability to aseptically gown into classified manufacturing spaces
Ability to complete work both independently with minimal supervision
Ability to prioritize and organize work to deliver assignments according to established schedules and deadlines
Ability to effectively collaborate with coworkers and internal clients
Ability to support audit readiness for the laboratory
Familiarity with United States Pharmacopeia and European Pharmacopeia
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
Expertise 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
High School Diploma and at least 4 years of laboratory experience in a cGMP environment; or Associate’s degree in Life Science, Pharmaceutical, or related field with at least 2 years of laboratory experience in a cGMP environment; or Bachelor’s degree in Life Science or Biology with no prior experience in a cGMP environment

Nice To Haves

BioWork Certificate

Responsibilities

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)
Enters data into the Laboratory Information Management System (LIMS)
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 informing and consulting with area management.
Partners with laboratory management in scheduling of daily, weekly, and non-routine testing and tasks.
Participate or lead laboratory equipment qualification or validation.
Performs other duties, as assigned.

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