Senior Quality Specialist - GMP/QA Lead

Katalyst CRO; Atlanta (GA); On-site; USD 90,000 - 130,000; Full time

Job summary

Katalyst CRO 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 and QC release testing to support product disposition.

Responsibilities include batch record reviews, final documentation approvals, and day-to-day batch release management. You will also assist audits and coordinate with internal/external partners while tracking

Qualifications

• Bachelor's degree in a scientific or allied health field.
• Experience providing QA support and oversight of GMP manufacturing operation.
• Experience leading event investigations, Root Cause Analysis and CAPA.
• Experience with Oracle, TrackWise, Veeva and related quality systems.
• Knowledge of current industry trends and ability to leverage latest technologies.

Responsibilities

• Reviews executed batch records and provides quality task approval for externally manufactured products.
• Performs final review of executed batch and critical systems documentation for acceptability per SOPs.
• Ensures presence and acceptability of all required documentation prior to product release.
• Supports the day-to-day management of the batch release process.
• Assists in preparing for quality audits and participates in external inspections as needed.
• Communicates proactively with internal and external partners and management.
• Maintains files so documents are readily accessible.

Skills

Communication

Critical Thinking

Risk-Based Thinking

MS Office

Quality Metrics

CAPA

TrackWise

Veeva

Oracle

Education

Bachelor's degree in science or allied health

Tools

TrackWise

Veeva

Oracle

Job description

Katalyst CRO 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 and QC release testing to support product disposition.

Responsibilities include batch record reviews, final documentation approvals, and day-to-day batch release management. You will also assist audits and coordinate with internal/external partners while tracking