Quality Systems Specialist - GxP & CAPA Expert

ProBio; Pennington (NJ); On-site; USD 70,000 - 90,000; Full time

Benefits offered by this job

Medical, dental, vision insurance

401(k) retirement plan with company 1:

Paid parental leave

Paid time off, holidays

Job summary

ProBio is seeking a QA professional to administer and continuously improve its Quality Management System for GMP compliance across clinical and commercial CGTP products. You will handle deviations, CAPA, change controls, investigations, and risk management while collaborating with internal teams and external resources to sustain a culture of quality.

The role requires a Bachelor’s degree in a scientific field with 3+ years of QA experience, familiarity with GxP document systems, and strong

Qualifications

• Bachelor’s degree in a scientific discipline with 3+ years of QA experience in pharma/biotech.
• Experience with GxP document management systems (e.g., Veeva QualityDocs, Veeva QMS, TrackWise).
• Knowledge of GxP document control, change control, CAPA, deviations, and lab investigations.
• Knowledge of quality risk management and root cause analysis.
• Understanding of biologics manufacturing and lab activities.
• GMP regulations and compliance requirements.
• Strong communication and proactive customer service attitude.
• Proficient with Microsoft Office.
• Ability to work virtually/in a fast-paced matrixed environment.

Responsibilities

• Maintain and continuously improve QMS for GMP compliance at the Hopewell, NJ facility.
• Manage QA reviews and approvals for Change Control, CAPA, Deviations, Lab investigations, incidents, complaints, and OOS reports.
• Facilitate Root Cause Analysis and Investigations; ensure timely CAPA closure and effectiveness verification.
• Monitor quality system performance and overdue actions.
• Support development and monitoring of quality metrics and KPIs.
• Analyze quality trends and generate management review reports.
• Participate in customer audits, regulatory inspections, and internal audits.
• Coordinate responses to audit observations and findings.
• Maintain inspection readiness at all times.
• Perform other tasks as needed.

Skills

QA experience

GxP knowledge

Root cause analysis

CAPA

Change control

Lab investigations

Communication skills

MS Office

Inspection readiness

Education

Bachelor’s degree in a scientific discipline

Tools

Veeva QualityDocs

Veeva QMS

TrackWise QMS

Job description

ProBio is seeking a QA professional to administer and continuously improve its Quality Management System for GMP compliance across clinical and commercial CGTP products. You will handle deviations, CAPA, change controls, investigations, and risk management while collaborating with internal teams and external resources to sustain a culture of quality.

The role requires a Bachelor’s degree in a scientific field with 3+ years of QA experience, familiarity with GxP document systems, and strong