QA Engineer, Drug Substance Manufacturing - 12-Hour GMP Ops

FUJIFILM Biotechnologies; Holly Springs (NC); On-site; USD 110,000 - 150,000; Full time

Job summary

FUJIFILM Biotechnologies in Holly Springs, NC seeks a QA Engineer for DSM Operations to drive quality oversight from development through startup to commercial operation.

Responsibilities include SME for DSM documents, change control oversight, QA lifecycle of documents, and ensuring timelines meet regulatory standards; collaborate across FUJIFILM sites and participate in inspections; support 24/7 manufacturing; travel may be required.

Qualifications

• BS/BA in Life Sciences or Engineering with 5+ years in GMP environment.
• MS in Life Sciences or Engineering with 3+ years in GMP environment.
• PhD in Life Sciences or Engineering with 1+ year in GMP environment.

Responsibilities

• SME role within QA for development of DSM documents, processes and procedures.
• Assess impact of system and process changes and maintain change control oversight to keep Manufacturing Systems validated.
• Generate, review and approve QA documentation to support operational readiness and QA of manufacturing in a cGMP facility.
• Ensure project and operational quality objectives are met within timelines.
• Collaborate with FUJIFILM Biotechnologies sites to streamline processes and improve efficiency.
• Support regulatory inspections and continuous improvement initiatives.
• Flexible to support 24/7 manufacturing operations.

Skills

Quality Assurance

Regulatory Compliance

Communication

Problem Solving

Team Collaboration

Education

BS/BA in Life Sciences or Engineering

MS in Life Sciences or Engineering

PhD in Life Sciences or Engineering

Tools

Smartsheet

TrackWise

MasterControl

Kneat validation

Job description

FUJIFILM Biotechnologies in Holly Springs, NC seeks a QA Engineer for DSM Operations to drive quality oversight from development through startup to commercial operation.

Responsibilities include SME for DSM documents, change control oversight, QA lifecycle of documents, and ensuring timelines meet regulatory standards; collaborate across FUJIFILM sites and participate in inspections; support 24/7 manufacturing; travel may be required.