Senior QC Analyst - 24/7 Lab Testing & Support

FUJIFILM Biotechnologies; Holly Springs (NC); On-site; USD 70,000 - 90,000; Full time

Job summary

FUJIFILM Biotechnologies in Holly Springs, NC is seeking a Sr. Analyst 1, Quality Control to join a 24x7 QC team performing routine testing on manufacturing batch samples, clean utilities and environmental monitoring across labs.

You will learn and perform testing across multiple QC labs, support qualification studies, assist with OOS investigations, and help implement LEAN/Six Sigma principles.

Qualifications

• Bachelor's degree with 2+ years of QC experience or Master's degree 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.

Responsibilities

• Performs basic testing across QC labs (e.g., Bioburden, Endotoxin, HPLC, UV280, TOC) per SOPs.
• Executes advanced lab testing and supports all laboratory assays; acts as SME and trainer for at least one test.
• Leads sample collection and manages sample logistics for testing.
• Supports testing for 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 onboarding of new staff.
• Embraces LEAN lab and six sigma principles.
• Champions projects and project management as assigned.
• Performs other duties, as assigned.

Skills

QC testing

GMP experience

LIMS experience

Documentation skills

Education

Bachelor's degree in a scientific field

Master's degree

Tools

LIMS software

Document control systems

Job description

FUJIFILM Biotechnologies in Holly Springs, NC is seeking a Sr. Analyst 1, Quality Control to join a 24x7 QC team performing routine testing on manufacturing batch samples, clean utilities and environmental monitoring across labs.

You will learn and perform testing across multiple QC labs, support qualification studies, assist with OOS investigations, and help implement LEAN/Six Sigma principles.