GMP Training & Qualification Lead – Biologics

Merck & Co.; Rahway (NJ); On-site; USD 117,000 - 184,000; Full time

Benefits offered by this job

Medical

Dental

Vision care

401(k)

Paid holidays

Vacation

Sick days

Job summary

Merck & Co. in Rahway, NJ seeks a Sr. Specialist for Training Coordination and Compliance Operations to coordinate GMP training, qualification programs, and LMS activities.

The role supports the Next Generation Biologics facility, working with Operations, Quality, and SMEs to ensure trained, qualified personnel for GMP activities. The candidate will manage training records, develop curricula, monitor compliance metrics, and contribute to continuous improvement while collaborating across

Qualifications

• Bachelor's degree in Biological Sciences, Engineering, or related discipline with 5+ years of experience; Master's with 3+ years preferred.
• Experience coordinating GMP training, qualification programs, and LMS.
• Proficiency with qualification tracking, documentation practices, and compliance reporting.

Responsibilities

• Coordinate GMP training and qualification programs for NGB Operations.
• Establish role-based training requirements with Operations and SMEs.
• Monitor compliance, identify gaps, and drive remediation actions.
• Maintain training records and controlled documents per cGMP and data integrity.
• Manage LMS activities: curricula, assignments, tracking, and reporting.
• Lead instructor-led training and coordinate onboarding and cross-training.

Skills

GMP Training Coordination

LMS Administration

Qualification Tracking

Documentation Management

Cross-functional Collaboration

Data Analytics

Regulatory Compliance

Education

Bachelor's degree in Biological Sciences/Engineering

Master's degree (relevant field)

Job description

Merck & Co. in Rahway, NJ seeks a Sr. Specialist for Training Coordination and Compliance Operations to coordinate GMP training, qualification programs, and LMS activities.

The role supports the Next Generation Biologics facility, working with Operations, Quality, and SMEs to ensure trained, qualified personnel for GMP activities. The candidate will manage training records, develop curricula, monitor compliance metrics, and contribute to continuous improvement while collaborating across