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 OverviewAt 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
Major Accountabilities
Provides facility support through the collection and testing of site clean utilities (e.g., water, stem, 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 batchesReviews laboratory testing results and enters data into the Laboratory Information Management System (LIMS)Performs environmental monitoring of controlled manufacturing environmentsEnsures laboratory maintains inspection readiness, data integrity, and Current Good Manufacturing Practice (CGMP) complianceAssists management with technical services, such as initiating events (e.g., deviations and non-conformances) within quality systemsIdentifies and solves problems while consulting and under the direction of managementAssists with laboratory equipment qualification and validation activitiesParticipates 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 behaviorsEffective communication, both written and verbalTechnical writing and problem-solving skillsAbility to complete work both independently and under guidance from SupervisionAbility to systematically approach daily tasksAbility to effectively collaborate with coworkers and internal clientsKnowledge of United States Pharmacopeia and European PharmacopeiaAbility to support audit readiness for the laboratoryWillingness to incorporate lean lab and six sigma principles into the work environmentAbility to manage and complete tasks according to a structured planKnowledge and familiarity with data management systems (e.g., TrackWise, LIMS) and capability to learn basic use and navigation within the systemsMust be flexible to support 24/7 manufacturing facility
Minimum Education and Experience Requirements
High School Diploma/GED with 6 years of Microbiology experience; orAssociate’s degree in Life Science, Pharmaceutical, or related field with 2-4 years of Microbiology experience; orBachelor’s degree in Life Science or Biology with 1-2 years of Microbiology experienceExperience 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 minutesAbility to sit for prolonged periods of time 60 to 120 minutesAbility 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
To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid.
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EEO InformationFujifilm 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 InformationIf 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 (HR_FDBU@fujifilm.com).
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