Senior QC Analyst 24/7 GMP Lab Testing

Merck & Co.; Holly Springs (NC); On-site; USD 75,000 - 110,000; Full time

Job summary

FUJIFILM Biotechnologies in Holly Springs, NC seeks a Sr. Analyst 1, Quality Control (QC) to perform routine testing across QC labs for Urgent/STAT manufacturing support. This role is part of a 24x7 team, learning and performing across multiple labs under SOPs.

You will lead sample collection, support qualification and study testing, investigate OOS events, and contribute to continuous improvement using LEAN and Six Sigma. Requires GMP knowledge, LIMS experience, and strong documentation skills.

Qualifications

• Bachelor's degree in a relevant science field with 2+ years of QC experience.
• Master's degree with 0 years of experience is acceptable.
• Experience with aseptic production and 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 and document control proficiency.
• Experience reviewing and editing technical documents.

Responsibilities

• Performs basic testing across QC labs per SOPs for manufacturing samples.
• Executes advanced lab testing and serves as SME and trainer.
• Leads sample collection and manages sample logistics.
• Supports qualification and study-directed testing.
• Investigates routine OOS assays and events.
• Writes and assists with document preparation and review.
• Manages project timelines and supports training.

Skills

GMP environment experience

Aseptic production experience

QC testing

LIMS experience

Document control

OOS investigation

Education

Bachelor's degree in a relevant science field

Master's degree

Tools

LIMS

Job description

FUJIFILM Biotechnologies in Holly Springs, NC seeks a Sr. Analyst 1, Quality Control (QC) to perform routine testing across QC labs for Urgent/STAT manufacturing support. This role is part of a 24x7 team, learning and performing across multiple labs under SOPs.

You will lead sample collection, support qualification and study testing, investigate OOS events, and contribute to continuous improvement using LEAN and Six Sigma. Requires GMP knowledge, LIMS experience, and strong documentation skills.