Lead QC Associate II

Fujifilm•Morrisville, NC

2d•Onsite

About The Position

The Lead QC Associate II role in Quality Control Microbiology is crucial for overseeing and guiding the critical operational functions of the QC Microbiology laboratory. This position holds the responsibility for conducting microbiological assays, as well as for effectively training junior analysts in these areas. The incumbent will operate largely autonomously, ensuring technical issues are promptly escalated to laboratory management. 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
Superior 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
In-depth understanding and working knowledge of 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
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 8 years of laboratory experience in a cGMP environment; or
Associate’s degree in Life Science, Pharmaceutical, or related field with at least 6 years of laboratory experience in a cGMP environment; or
Bachelor’s degree in Life Science or Biology with at least 4 years of experience in a cGMP environment

Nice To Haves

BioWork Certificate

Responsibilities

Performs complex microbiological testing per department Standard Operating Procedures (SOPs) and test methods for samples associated manufactured batches. Testing may include, but is not limited to, Bioburden, Endotoxin, Culture Purity, and Microbial Identifications.
Reviews technical data, authors routine and periodic laboratory reports (e.g., EM trend reports) and contributes to technical documentation and assessments.
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.
Leads laboratory deviations and investigations.
Identifies and solves problems while informing and consulting with area management.
Participates in project developments from concept through execution, ensuring alignment with organizational goals.
Partners with laboratory management in scheduling of daily, weekly, and non-routine testing and tasks.
Provides technical guidance and mentorship to junior analysts.
Participate or lead laboratory equipment qualification or validation.
Troubleshoots assay and method issues with the support of laboratory management.
Troubleshoots laboratory equipment when issues arise.
Performs other duties, as assigned.