QA Specialist, Drug Product — Validation & GMP Oversight

FUJIFILM; Holly Springs (NC); Vor Ort; USD 90.000 - 125.000; Vollzeit

Zusammenfassung

FUJIFILM Holdings America Corporation is seeking a QA Specialist for Drug Product in North Carolina. The role drives Quality oversight from DP manufacturing readiness through startup to commercial operation, coordinating validation, lifecycle documentation, and regulatory readiness.

You will support cross-functional teams, manage change controls, and collaborate with global peers to ensure compliant, on-time delivery in a fast-paced environment. Onsite role with some travel expected.

Qualifikationen

• Bachelor’s degree in Life Sciences or Engineering; 2+ years in industry.
• Master’s degree in Life Sciences or Engineering; 0+ years.
• 1+ years in GMPregulated environment.
• Experience in Validation, cGMP manufacturing operations and/or Quality oversight in an FDA facility.

Aufgaben

• Supports the development of documents, processes and procedures for the Drug Product program.
• Assesses the impact of system and process modifications and maintains change management oversight to keep Manufacturing systems validated from startup to commercial.
• Provides oversight and approval of lifecycle documentation including risk & impact assessments, specs, validation plans and reports.
• Generates, reviews and approves QA procedures for validation approach and lifecycle documents for Manufacturing Systems.
• Generates, reviews and approves QA documentation and processes for operational readiness and QA support of manufacturing in a cGMP facility.
• Ensures completion of project and operational quality objectives within timelines.
• Provides shop floor QA support including AQL, critical process step verification, issue resolution, line clearance and alarm response.
• Participates in optimization or improvement initiatives; supports regulatory inspections.
• Performs other duties as assigned.

Kenntnisse

Communication

Time management

Problem solving

Collaboration

GMP knowledge

Genki culture

Travel flexibility

Ausbildung

Bachelor’s degree in Life Sciences or Engineering

Master’s degree in Life Sciences or Engineering

Tools

Smartsheet

Trackwise

Veeva

Kneat

PAS-X

Jobbeschreibung

FUJIFILM Holdings America Corporation is seeking a QA Specialist for Drug Product in North Carolina. The role drives Quality oversight from DP manufacturing readiness through startup to commercial operation, coordinating validation, lifecycle documentation, and regulatory readiness.

You will support cross-functional teams, manage change controls, and collaborate with global peers to ensure compliant, on-time delivery in a fast-paced environment. Onsite role with some travel expected.