Senior QA Specialist: GMP Batch Release & Audit Support

Katalyst CRO; Wilmington (DE); On-site; USD 92,000 - 125,000; Full time

Job summary

VCGT seeks an Operational Area Senior Quality Specialist to provide QA support for manufacturing operations, analytical labs, and materials management for external programs. You will review batch data, deviations, in-process data, EM data, QC release testing, and other quality systems documentation to support product disposition.

The role requires experience overseeing GMP manufacturing operations, leading CAPA investigations, and utilizing TrackWise/Oracle/Veeva.

Qualifications

• Bachelor's degree in a scientific or allied health field.
• Experience providing QA support and oversight of GMP manufacturing operations.
• Experience leading event investigations, Root Cause Analysis and CAPA.
• Familiar with Oracle, TrackWise and Veeva systems.

Responsibilities

• Review batch records and provide approval for quality tasks for externally manufactured products.
• Perform final review of batch and critical systems documentation to determine acceptability.
• Ensure required documentation is present prior to product release.
• Support day-to-day management of the batch release process.
• Assist in quality audits and participate in corporate/external inspections as needed.
• Proactively communicate with internal and external partners and management.
• Maintain files for easy retrieval of documents.
• Assist with monthly/quarterly Quality System data review metrics and reporting.
• Escalate critical and major findings to Quality management and monitor KPIs.

Skills

Communication skills

Critical thinking

Risk-based decision making

MS Office

Cell/Gene Therapy QA

QA oversight GMP

CAPA investigations

Industry trends

Education

Bachelor's degree in science

Tools

Oracle

TrackWise

Veeva

Job description

VCGT seeks an Operational Area Senior Quality Specialist to provide QA support for manufacturing operations, analytical labs, and materials management for external programs. You will review batch data, deviations, in-process data, EM data, QC release testing, and other quality systems documentation to support product disposition.

The role requires experience overseeing GMP manufacturing operations, leading CAPA investigations, and utilizing TrackWise/Oracle/Veeva.