QA Operations Engineer, Drug Product — 2nd Shift

FUJIFILM Biotechnologies; Holly Springs (NC); On-site; USD 90,000 - 120,000; Full time

Job summary

FUJIFILM Biotechnologies in the United States is seeking a QA Operations Engineer to support second shift QA oversight for Drug Product Manufacturing. The role ensures GMP-compliant document control, change management, and quality system maintenance, with a progression to a 2-2-3, 12-hour rotating schedule.

Requires a Bachelors with 5 years (or Masters with 3 years) in a regulated GMP environment. Responsibilities span SME-level documentation, QA approvals, line clearance, deviation assessment,

Qualifications

• Bachelor’s degree with 5 years of related experience, or Master’s with 3 years in a GMP setting.
• Experience in regulated drug product manufacturing is required.
• Strong documentation, change control, and QA oversight capabilities.

Responsibilities

• Supports SME development of documents, processes and procedures for the Drug Product program.
• Generates, reviews and approves QA documentation and procedures for operational readiness and QA support.
• Provides shop floor QA support including line clearance, alarm response, and WO oversight.
• Ensures timely achievement of quality objectives and maintains validated state of systems.
• Oversees risk assessments, change management and lifecycle documentation.
• Participates in regulatory inspections and improvement initiatives.
• Performs other duties as assigned.

Skills

QA Oversight

Document control

GMP experience

Cross-functional collaboration

Problem solving

Education

Bachelor's degree + 5 years related experience

Master's degree + 3 years related experience

Tools

Trackwise

Veeva

PAS-X

Smartsheet

Kneat

Job description

FUJIFILM Biotechnologies in the United States is seeking a QA Operations Engineer to support second shift QA oversight for Drug Product Manufacturing. The role ensures GMP-compliant document control, change management, and quality system maintenance, with a progression to a 2-2-3, 12-hour rotating schedule.

Requires a Bachelors with 5 years (or Masters with 3 years) in a regulated GMP environment. Responsibilities span SME-level documentation, QA approvals, line clearance, deviation assessment,