Quality Systems Specialist - GxP & QMS Expert

GenScript Biotech Corp.; Pennington (NJ); On-site; USD 70,000 - 90,000; Full time

Job summary

GenScript Biotech Corp. is seeking a QA specialist to contribute to the administration, maintenance, and continuous improvement of ProBio's Quality Management System (QMS) to ensure GMP compliance for clinical and commercial Cell and Gene Therapy products manufactured and/or tested at the Hopewell, NJ facility.

The role collaborates cross-functionally with internal teams, customers, and external resources to ensure compliance and drive a culture of quality and operational excellence.

Qualifications

• Bachelor's degree in a scientific discipline with 3+ years of QA experience.
• Experience with GxP document management systems and QMS.
• Knowledge of GMP requirements and regulatory expectations.
• Proactive communicator with strong problem-solving skills.
• Proficiency in Microsoft Office suite.

Responsibilities

• QA review and approval of documentation related to Change Control, CAPA, deviations, investigations, and OOS reports.
• Maintain and improve QMS alignment with worldwide GMP regulations.
• Coordinate responses to audit observations and inspection findings.
• Support Root Cause Analysis and verification of CAPA effectiveness.
• Monitor quality system performance and track overdue actions.

Skills

GxP knowledge

QMS management

CAPA

Change Control

Deviations handling

Lab investigations

Data analysis

Investigations tools

Education

BSc in a scientific discipline

Tools

Veeva QualityDocs

Veeva QMS

TrackWise QMS

Job description

GenScript Biotech Corp. is seeking a QA specialist to contribute to the administration, maintenance, and continuous improvement of ProBio's Quality Management System (QMS) to ensure GMP compliance for clinical and commercial Cell and Gene Therapy products manufactured and/or tested at the Hopewell, NJ facility.

The role collaborates cross-functionally with internal teams, customers, and external resources to ensure compliance and drive a culture of quality and operational excellence.