Senior QA Lead - GMP, Batch Release & Compliance

Creative Solutions Services, LLC; Durham (NC); On-site; USD 90,000 - 130,000; Full time

Job summary

Creative Solutions Services, LLC is seeking an Operational Area Senior Quality Specialist to provide QA support across manufacturing, analytical labs, and materials management for external programs. You will review batch data, deviations, and QC release testing to support product disposition.

The role requires leading event investigations, CAPA, and applying risk-based decision making with GMP oversight. Strong communication and MS Office skills are essential, with familiarity in TrackWise/Veeva

Qualifications

• BS degree in a scientific or allied health field or equivalent experience.
• Experience providing QA support and oversight of GMP manufacturing.
• Experience leading event investigations and CAPA.
• Experience with TrackWise, Veeva, and Oracle systems.
• Knowledge of current industry trends and technologies.

Responsibilities

• Review batch records and approve quality tasks for externally manufactured products.
• Perform final review of batch and critical documentation for acceptability.
• Ensure required documentation is present prior to product release.
• Support day-to-day batch release processes.
• Assist audits and external inspections as needed.
• Communicate with internal/external partners and management.
• Maintain easily retrievable documentation files.
• Assist monthly/quarterly quality system data reviews.
• Escalate major findings to Quality management and monitor KPIs.

Skills

Strong communication

Critical thinking

Risk-based decisions

Microsoft Office

GxP QA experience

CAPA investigations

Event investigations

Root Cause Analysis

Aseptic processing

Quality metrics dashboards

GMP oversight

Education

Bachelor's degree in science

Tools

TrackWise

Veeva

Oracle

Job description

Creative Solutions Services, LLC is seeking an Operational Area Senior Quality Specialist to provide QA support across manufacturing, analytical labs, and materials management for external programs. You will review batch data, deviations, and QC release testing to support product disposition.

The role requires leading event investigations, CAPA, and applying risk-based decision making with GMP oversight. Strong communication and MS Office skills are essential, with familiarity in TrackWise/Veeva