Quality Systems Specialist - GxP, QA & Compliance

GenScript Biotech Corp.; Northern (KY); Hybrid; USD 70,000 - 90,000; Full time

Benefits offered by this job

Medical Insurance

Dental Insurance

Vision Insurance

401(k) with company match

Parental leave

Paid time off

FSA/HSA

Job summary

GenScript Biotech Corporation, via its ProBio Inc. unit in the United States, seeks a QA professional to administer and improve the Quality Management System for Cell and Gene Therapy products.

You will handle deviations, CAPA, change controls, investigations, risk management, and document control to ensure global GxP compliance. You will collaborate with internal and external teams to sustain inspection readiness, drive quality metrics, and support regulatory inspections while maintaining

Qualifications

• Bachelor’s degree in a scientific discipline with 3+ years of QA/GxP experience in pharma/biotech.
• Experience with GxP document management systems and QMS platforms (e.g., Veeva, TrackWise).
• Knowledge of GxP Document Control, Change Control, CAPA, Deviations, and Lab investigations.
• Solid understanding of GMP regulations and regulatory requirements.
• Strong communication and documentation skills; able to work virtually and collaboratively.

Responsibilities

• Maintain and improve QMS for clinical and commercial C&GT products to ensure GxP compliance.
• Review and approve Change Controls, CAPAs, Deviations, and Investigations per QA procedures.
• Support root cause analysis and effective CAPA implementation with timely verification.
• Monitor quality metrics and overdue actions; report on KPIs.
• Participate in audits, inspections, and customer inquiry responses.
• Coordinate readiness for regulatory inspections and internal audits.

Skills

GxP QA

QMS

CAPA

Change Control

Deviation Investigation

Root Cause Analysis

Regulatory Compliance

Documentation Control

Communication

Education

Bachelor’s degree in a scientific discipline

Tools

Veeva QualityDocs

Veeva QMS

TrackWise

Job description

GenScript Biotech Corporation, via its ProBio Inc. unit in the United States, seeks a QA professional to administer and improve the Quality Management System for Cell and Gene Therapy products.

You will handle deviations, CAPA, change controls, investigations, risk management, and document control to ensure global GxP compliance. You will collaborate with internal and external teams to sustain inspection readiness, drive quality metrics, and support regulatory inspections while maintaining