GMP Training & Compliance Coordinator - Biologics

Socket.dev; Rahway (NJ); On-site; USD 117,000 - 184,000; Full time

Job summary

Merck in Rahway, NJ seeks a Sr. Specialist, Training Coordination, Compliance Operations to lead GMP training and qualification programs for the Next Generation Biologics facility.

You will administer LMS activities, manage documentation, and partner with Operations, Quality, and SME stakeholders to ensure compliant, role-based training across multi-product operations. The role emphasizes maintaining training records, implementing digital learning tools, and delivering instructor-led and digital

Qualifications

• Education: Bachelor’s in Biological Sciences, Engineering, or related with 5+ years experience; Master’s with 3+ years.
• Experience in GMP training and qualification programs within pharma/biotech or regulated environments.
• Developing training curricula and qualification programs; role-based training requirements.
• Coordinating GMP training programs, qualification management, and curriculum administration.
• Managing training records, qualification tracking, and compliance reporting within an LMS.
• Leading instructor-led, virtual, self-paced, and on-the-job training programs.
• Monitoring compliance and qualification status; remediation actions.
• Supporting digital learning technologies and electronic work instructions.

Responsibilities

• Coordinate GMP training and qualification programs supporting NGB Operations.
• Partner with Operations leadership and SMEs to establish role-based training requirements.
• Monitor training compliance, identify gaps, and drive remediation.
• Manage training records and controlled documents per cGMP and data integrity standards.
• Administer LMS activities: curriculum management, assignments, tracking, reporting.
• Lead instructor-led training sessions and onboarding, qualification, and cross-training.
• Deliver training on GMP and process-related procedures as applicable.
• Prepare qualification status reports, metrics dashboards, and training documentation.
• Evaluate training effectiveness and drive continuous improvement.

Skills

GMP Training

LMS Administration

Qualification Tracking

Curriculum Development

Data Analysis

Documentation Management

Project Coordination

Public Speaking

Stakeholder Collaboration

Education

Bachelor's degree in Biological Sciences, Engineering, or related field

Master's degree in relevant field

Tools

LMS (Learning Management System)

Data Analytics Tools

Dashboard Reporting

Electronic Work Instructions

Job description

Merck in Rahway, NJ seeks a Sr. Specialist, Training Coordination, Compliance Operations to lead GMP training and qualification programs for the Next Generation Biologics facility.

You will administer LMS activities, manage documentation, and partner with Operations, Quality, and SME stakeholders to ensure compliant, role-based training across multi-product operations. The role emphasizes maintaining training records, implementing digital learning tools, and delivering instructor-led and digital