Senior Analyst 1, QC Testing

The Sr. Analyst 1, Quality Control (QC) All QC Team is responsible for performing routine testing required for Urgent/STAT testing of manufacturing batch samples, clean utility, environmental monitoring. This role is part of a 24x7 team that supports testing/sampling across all of the QC laboratories required for urgent testing/Manufacturing support. The role will learn and perform testing/sampling across multiple labs in QC.

Company Overview

FUJIFILM Biotechnologies is building the future of bioproduction in Holly Springs, North Carolina. By end of 2025, we’ll open North America’s largest end-to-end CDMO biopharmaceutical manufacturing facility, offering drug substance production, fill-finish, and packaging under one roof.

We’re looking for passionate, mission-driven people to help us realize this exciting vision and deliver the next vaccine, cure, or therapy. We offer a dynamic work environment and we’re proud to cultivate a culture that will fuel your purpose, energy, and drive—what we call Genki. Ready to shape the future of medicine? Let’s transform healthcare together!

Holly Springs, North Carolina, combines small-town warmth with proximity to Raleigh’s thriving tech scene, making it the perfect blend of community and opportunity.

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

Job Description

What You'll Do:

• Performs basic testing that spans all of the QC labs (e.g., Bioburden, Endotoxin, HPLC, UV280, TOC, etc.) per department Standard Operating Procedures (SOPs) and test methods for samples associated manufactured batches
• Executes advanced lab testing and support for all laboratory assays for all samples, and acts as a Subject Matter Expert (SME) and qualified trainer of at least one test
• Leads sample collection and manages sample logistics for testing
• Supports testing for all qualification and study directed testing
• Supports investigation of routine OOS assays and events
• Conducts qualification and validation protocols
• Reviews intermediate lab testing results
• Troubleshoots complex assays
• Writes and assists with document preparation and review
• Manages project timelines
• Assists management with training and on-boarding of new staff as needed
• Embraces LEAN lab and six sigma principles and applies them to laboratory processes
• Champions projects and project management as assigned
• Performs other duties, as assigned
  
  

Minimum Qualifications

• Bachelor’s with 2 years of relevant QC experience OR
• Master’s with 0 years of experience
• Experience with aseptic production & support
• 1-3 years in a GMP environment
• Advanced understanding of GMP, GLP, GDP requirements
• Advanced knowledge of QC testing and laboratory experience
• LIMS experience
• Experience with document control including reviewing and editing technical documents
  
  

Preferred Qualifications

• 4 years of previous experience working within QC or with GXP or quality systems is an advantage
• Advanced experience in a GMP QC Laboratory, advanced knowledge of all compendial test methods.
  
  

Working Conditions & Physical Requirements

• Ability to discern audible cues
• Ability to inspect or perform a task with 20/20 corrected vision, visual acuity, including distinguishing color
• Ability to ascend or descend ladders, scaffolding, ramps, etc.
• Ability to stand for prolonged periods of time (Daily up to 60 minutes)
• Ability to sit for prolonged periods of time (Daily up to 60 minutes)
• Ability to conduct activities using repetitive motions that include writs, hands and/or fingers.
• 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.
  
  

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.

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 (FDBN_PNC@fujifilm.com).