Senior Specialist, Training Coordination & Compliance Operations

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

Job Description

The Biologics Process Research & Development organization within our Company Research Labs is responsible for developing the drug substance manufacturing processes for our Company's biologics pipeline. We work closely with colleagues in Discovery, Pre‑clinical, and Early Development to rapidly develop processes for diverse biotherapeutics and efficiently produce material to supply clinical trials. We are also responsible for commercial process development, and development and implementation of new technologies. We work with our partners in our Company Manufacturing Division to commercialize and launch new products.

Job Description

The Biologics Process Research & Development organization within our Company Research Labs is responsible for developing the drug substance manufacturing processes for our Company's biologics pipeline. We work closely with colleagues in Discovery, Pre‑clinical, and Early Development to rapidly develop processes for diverse biotherapeutics and efficiently produce material to supply clinical trials. We are also responsible for commercial process development, and development and implementation of new technologies. We work with our partners in our Company Manufacturing Division to commercialize and launch new products. This role will support the Next Generation Biologics (NGB) facility, which will be a premier, state‑of‑the‑art facility, that is a key part of our Chemistry, Manufacturing, and Controls (CMC) hub at our site headquarters in Rahway, NJ. This facility will be fully online in the next few years, both in terms of facility construction and organizational realization. The GMP facility is designed for multi-product operations with flexible operating suites, which can adjust as the clinical pipeline demands change. It can meet all historic, currently existing, and cutting‑edge biologics program demands from supporting development to pilot scale, small and large scale potent material handling, and the ability to integrate new technologies and cell‑line platforms.

The Sr. Specialist, Training Coordination, Compliance Operations, is responsible for coordinating GMP training and qualification programs that support personnel qualification and compliance within the NGB facility. The role manages qualification programs, training curricula; administers Learning Management System (LMS) activities, training records, and qualification documentation; coordinates SOP training requirements; and monitors training compliance metrics. In partnership with Operations, Quality, and Subject Matter Experts (SMEs), this position maintains GMP training documentation and ensures personnel are appropriately trained and qualified to perform GMP activities.

Job Responsibilities

• Coordinate GMP training and qualification programs supporting NGB Operations
• Partner with Operations leadership, SMEs, and process owners to establish role‑based training and qualification requirements
• Monitor training compliance and qualification status, identify gaps, and drive remediation activities
• Manage training records and controlled documents in compliance with cGMP, Data Integrity, and Records Management requirements
• Administer and maintain LMS activities, including curriculum management, training assignments, qualification tracking, compliance monitoring, and reporting
• Lead instructor‑led training sessions and coordinate onboarding, qualification, and cross‑training programs
• Coordinate and deliver training on GMP and process‑related procedures, as applicable
• Prepare and communicate qualification status reports, compliance metrics, dashboards, and training documentation
• Evaluate training effectiveness and drive continuous improvement through metrics, performance indicators, and employee feedback
• Support implementation of digital learning technologies and tools that enhance manufacturing operations
• Serve as a resource for GMP training compliance, qualification programs, documentation practices, and learning systems

Education

Required Education, Experience and Skills:

• Bachelor's degree in Biological Sciences, Engineering , or a related discipline with a minimum of 5 years of relevant experience;
• Master's degree with a minimum of 3 years of relevant experience

Experience & Skills

• Supporting GMP training and qualification programs within pharmaceutical, biotechnology, biologics, or other regulated environments
• Developing training curricula, qualification programs, and role‑based training requirements
• Coordinating GMP training programs, qualification management, and curriculum administration
• Managing training records, qualification tracking, and compliance reporting within an LMS
• Coordinating and leading instructor‑led, virtual, self‑paced, and on‑the‑job training programs
• Monitoring training compliance and qualification status and implementing remediation actions
• Utilizing training metrics and analytics to monitor compliance and drive continuous improvement
• Managing controlled training documentation and supporting SOP implementation within GMP quality systems
• Leading training‑related projects and initiatives from planning through execution
• Supporting digital learning technologies, electronic work instructions, and training management systems
• Strong written, verbal, facilitation, and presentation skills
• Strong organizational, planning, and problem‑solving skills
• Ability to manage multiple projects, priorities, and deadlines in a fast‑paced GMP environment
• Ability to collaborate across functions and influence stakeholders to achieve business objectives
• Proficiency in LMS administration, reporting, and compliance tracking
• Knowledge of cGMP regulations, training compliance requirements, and documentation practices

Preferred Experience And Skills

• Developing dashboards and training metrics to monitor compliance, qualification status, and training effectiveness
• Implementing or supporting digital learning technologies,