Remote Quality Systems Specialist - GMP & QMS

GenScript/ProBio; South Dakota; On-site; 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

Commuter benefits

Job summary

GenScript USA Inc./ProBio Inc. seeks a QA professional to administer and improve the Quality Management System, ensuring GxP compliance for clinical and commercial cell and gene therapies at the Hopewell, NJ facility.

You will oversee deviations, CAPA, change controls, investigations, and documentation. You will collaborate cross-functionally with internal teams and customers, supporting audits, regulatory inspections, and ongoing training.

Qualifications

• Bachelor’s degree in a scientific discipline with 3+ years of QA experience in pharma, biotech or related environment.
• Experience with GxP document management systems and QMS tools.
• Knowledge of GxP Document Control, Change Control, CAPA, Deviation and Lab investigations.
• Understanding of quality risk management and investigation tools.
• Excellent verbal and written communication; proactive, customer-focused attitude.

Responsibilities

• Maintain and improve QMS ensuring GxP compliance for clinical and commercial products.
• QA review/approval of documentation related to Change Control, CAPA, Deviations, Lab Investigations, and OOS.
• Facilitate root cause analysis and ensure timely CAPA closure and verification.
• Monitor quality metrics and oversee KPI development and reporting.
• Participate in audits, regulatory inspections, and internal audits; support inspection readiness.

Skills

Communication

Problem-solving

Analytical thinking

Organization

Time management

Education

Bachelor’s degree in scientific discipline

Tools

Veeva QualityDocs

Veeva QMS

TrackWise QMS

Job description

GenScript USA Inc./ProBio Inc. seeks a QA professional to administer and improve the Quality Management System, ensuring GxP compliance for clinical and commercial cell and gene therapies at the Hopewell, NJ facility.

You will oversee deviations, CAPA, change controls, investigations, and documentation. You will collaborate cross-functionally with internal teams and customers, supporting audits, regulatory inspections, and ongoing training.