QA Operations Engineer, Drug Product (2-2-3 Shifts)

FUJIFILM; Holly Springs (NC); On-site; USD 85,000 - 105,000; Full time

Job summary

FUJIFILM Biotechnologies in Holly Springs, North Carolina, seeks a QA Operations Engineer to drive quality oversight in Drug Product Manufacturing during second shift, with future 2-2-3 12-hour rotations. The role collaborates with the DP Quality team and cross-functional groups to ensure validated, compliant operations and change-management processes.

Responsibilities include developing and approving QA documents, supporting manufacturing readiness, line clearance, and regulatory readiness,

Qualifications

• Bachelor’s degree with 5 years of related experience, or Master’s with 3 years.
• Experience in a regulated GMP environment.
• Strong documentation and QA oversight capabilities.

Responsibilities

• Performs SME role within QA for development of documents, processes, and procedures.
• Generates, reviews, and approves QA documentation for manufacturing readiness objectives and QA support of manufacturing operations in cGMP regulated facility.
• Manufacturing shop floor support, including AQL, critical process step verification, issue resolution, line clearance, alarm response, and work order oversight.
• Ensures project and operational quality objectives are met within desired timelines.
• Assess the impact of system and process modifications and maintains oversight of change management processes to ensure Manufacturing systems are maintained in a validated state through startup and into commercial operation.
• Provides oversight and approval of system and process lifecycle documentation, including risk and impact assessments, product, process and equipment specifications.
• Participates in optimization or improvement initiatives and support regulatory agency and third-party inspections.
• Performs other duties, as assigned.

Skills

QA oversight

GxP knowledge

QA documentation

Communication

Education

Bachelor’s degree

Master’s degree

Tools

TrackWise

Veeva

PAS-X

Smartsheet

Kneat

Job description

FUJIFILM Biotechnologies in Holly Springs, North Carolina, seeks a QA Operations Engineer to drive quality oversight in Drug Product Manufacturing during second shift, with future 2-2-3 12-hour rotations. The role collaborates with the DP Quality team and cross-functional groups to ensure validated, compliant operations and change-management processes.

Responsibilities include developing and approving QA documents, supporting manufacturing readiness, line clearance, and regulatory readiness,