QA Operations Engineer, Drug Product - 2nd Shift

FUJIFILM Biotechnologies; Holly Springs (NC); Sur place; USD 80 000 - 110 000; Plein temps

Résumé du poste

FUJIFILM Biotechnologies in Holly Springs, NC seeks a QA Operations Engineer to oversee DP quality during second shift with potential transitions to 12-hour rotating schedules. The role collaborates with DP Quality and cross‑functional teams to ensure compliant, validated operations from startup through commercial production.

Requirements include a Bachelor’s degree with 5 years of GMP experience or a Master’s with 3 years, and knowledge of Trackwise, Veeva, PAS-X, Smartsheet, or Kneat is

Qualifications

• Bachelor’s degree with 5 years’ related experience in a GMP environment.
• Master’s degree with 3 years’ related experience in a GMP environment.
• Experience working in a regulated GMP environment.

Responsabilités

• Serve as SME within QA for Drug Product documentation and procedures.
• Generate, review, and approve QA documents for manufacturing operations.
• Provide shop floor QA support including line clearance and alarm response.
• Ensure timing of quality objectives and regulatory readiness.
• Assess impact of changes and maintain validated state through startup to operation.
• Oversee lifecycle documents, risk assessments, and equipment specs.
• Participate in optimization and regulatory inspections.

Connaissances

QA oversight

Documentation

Regulatory

Communication

GMP experience

Critical thinking

Shift work

Formation

Bachelor's degree

Master's degree

Outils

Trackwise

Veeva

PAS-X

Smartsheet

Kneat

Description du poste

FUJIFILM Biotechnologies in Holly Springs, NC seeks a QA Operations Engineer to oversee DP quality during second shift with potential transitions to 12-hour rotating schedules. The role collaborates with DP Quality and cross‑functional teams to ensure compliant, validated operations from startup through commercial production.

Requirements include a Bachelor’s degree with 5 years of GMP experience or a Master’s with 3 years, and knowledge of Trackwise, Veeva, PAS-X, Smartsheet, or Kneat is