Senior Quality Specialist: GMP Batch Release & CAPA

Creative Solutions Services, LLC; Atlanta (GA); On-site; USD 90,000 - 120,000; Full time

Job summary

Creative Solutions Services, LLC is seeking an Operational Area Senior Quality Specialist to provide QA support for manufacturing operations, analytical labs, and materials management for external programs at VCGT. You will review batch data, deviations, in-process data, EM data, QC release testing and other quality systems documentation as needed in support of product disposition.

You will review batch records, perform final reviews, ensure documentation readiness for release, and support the

Qualifications

• Bachelor's degree in a scientific or allied health field or equivalent.
• Experience providing QA support and oversight of GMP manufacturing operations.
• Experience leading investigations, root cause analysis and CAPA.
• Familiarity with TrackWise, Oracle and Veeva systems.

Responsibilities

• Reviews executed batch records and provides QA approvals for externally manufactured products.
• Performs final review of batch and critical system documents for acceptability per SOPs.
• Ensures documentation is complete before product release and supports batch release.
• Help manage day-to-day batch release processes.
• Assist with quality audits and participate in external inspections.
• Communicates with internal and external partners and management.
• Maintain retrievable documentation and support metrics reporting.
• Escalate critical findings and monitor KPIs with Quality Systems and related areas.

Skills

Communication skills

Critical thinking

Risk-based decision making

Documentation review

Quality systems awareness

Problem solving

Microsoft Office proficiency

QA oversight experience

GXP/GMP knowledge

Root cause analysis

Education

Bachelor's degree in a scientific or allied health field

Tools

Oracle

TrackWise

Veeva

Job description

Creative Solutions Services, LLC is seeking an Operational Area Senior Quality Specialist to provide QA support for manufacturing operations, analytical labs, and materials management for external programs at VCGT. You will review batch data, deviations, in-process data, EM data, QC release testing and other quality systems documentation as needed in support of product disposition.

You will review batch records, perform final reviews, ensure documentation readiness for release, and support the