Senior QC Analyst – 24/7 Lab Coverage & SME Lead

FUJIFILM Holdings America Corporation; Holly Springs (NC); On-site; USD 65,000 - 90,000; Full time

Job summary

FUJIFILM Biotechnologies in Holly Springs, NC is seeking a Sr. Analyst 1, Quality Control to support urgent/STAT testing across multiple QC labs. You will participate in testing of batch samples, endotoxin, Bioburden, HPLC and other assays, and act as SME for at least one test.

The role involves sample collection, logis­tics, and participation in LEAN lab and Six Sigma initiatives, with a strong emphasis on documenting results and training staff.

Qualifications

• Bachelor’s degree or higher with QC/GMP experience.
• Experience with aseptic production and processes.
• 1-3 years in a GMP environment.
• Advanced understanding of GMP, GLP, GDP requirements.

Responsibilities

• Performs basic QC testing across labs per SOPs and methods.
• Acts as SME and trainer for at least one test.
• Leads sample collection and manages logistics for testing.
• Supports qualification, study testing, and investigation of OOS,
• Writes and reviews documentation and manages project timelines.
• Mentors new staff and supports LEAN/Six Sigma initiatives.

Skills

QC testing

GMP knowledge

LEAN/Six Sigma

Project management

SOP review

Education

Bachelor’s degree in a relevant field

Master’s degree

Tools

LIMS

Job description

FUJIFILM Biotechnologies in Holly Springs, NC is seeking a Sr. Analyst 1, Quality Control to support urgent/STAT testing across multiple QC labs. You will participate in testing of batch samples, endotoxin, Bioburden, HPLC and other assays, and act as SME for at least one test.

The role involves sample collection, logis­tics, and participation in LEAN lab and Six Sigma initiatives, with a strong emphasis on documenting results and training staff.