GMP Training & Compliance Lead for Biologics Ops

Merck; Rahway (NJ); On-site; USD 95,000 - 120,000; Full time

Job summary

Merck in Rahway, NJ seeks a Sr. Specialist, Training Coordination to oversee GMP training and qualification programs for the Next Generation Biologics (NGB) facility. You will manage LMS, curricula, and compliance, partnering with Operations, Quality, and SMEs to ensure robust training for a multi-product facility.

You will drive training records, dashboards, and continuous improvement efforts while coordinating onboarding and digital learning tools in a fast-paced GMP environment.

Qualifications

• GMP training coordination in pharma/biotech settings.
• Developing training curricula and qualification programs.
• Managing training records and compliance reporting via LMS.

Responsibilities

• Coordinate GMP training and qualification programs for NGB Operations.
• Establish role-based training requirements with SMEs and process owners.
• Monitor training compliance and drive remediation actions.
• Maintain training records and controlled documents per cGMP standards.
• Administer LMS activities, curriculum management, and reporting.
• Lead instructor-led and digital training sessions; coordinate onboarding.
• Prepare qualification status reports and compliance dashboards.
• Support digital learning technologies and documentation practices.
• Collaborate across functions to influence training outcomes.
• Ensure training metrics drive continuous improvement.

Skills

GMP training

LMS administration

Curriculum development

Data integrity compliance

cGMP knowledge

Qualification tracking

Education

Bachelor's degree in Biological Sciences or Engineering

Master's degree (preferred)

Tools

LMS

Job description

Merck in Rahway, NJ seeks a Sr. Specialist, Training Coordination to oversee GMP training and qualification programs for the Next Generation Biologics (NGB) facility. You will manage LMS, curricula, and compliance, partnering with Operations, Quality, and SMEs to ensure robust training for a multi-product facility.

You will drive training records, dashboards, and continuous improvement efforts while coordinating onboarding and digital learning tools in a fast-paced GMP environment.