Senior Training Specialist

Amneal India•Glasgow, KY

5h•Onsite

About The Position

The Senior Training Specialist ensures the integrity, compliance, and effectiveness of training programs supporting both GxP manufacturing and GDP pharmaceutical distribution/operational processes. This role is responsible for maintaining accurate training records, administering the Learning Management System (LMS), and ensuring all employees and contractors are trained in accordance with regulatory, quality, and operational requirements. This position plays a critical role in supporting distribution center operations, including warehouse processes, Manhattan Active WMS utilization, and pharmaceutical serialization (DSCSA compliance).

Requirements

Expertise in GxP manufacturing and GDP pharmaceutical distribution/operational processes.
Experience in maintaining accurate training records.
Proficiency in administering a Learning Management System (LMS).
Knowledge of regulatory, quality, and operational training requirements.
Experience supporting distribution center operations, including warehouse processes.
Familiarity with Manhattan Active WMS utilization.
Understanding of pharmaceutical serialization (DSCSA compliance).
Ability to develop and deploy training programs.
Ability to serve as a Subject Matter Expert (SME) trainer during regulatory inspections and audits.
Ability to develop SOP-based and system-based training materials.
Ability to ensure compliance with FDA, DEA, State guidelines and other relevant requirements.

Responsibilities

Evaluate change controls, CAPAs, deviations, and investigations to determine training impacts across the distribution environment.
Develop and deploy training programs that ensure operational readiness for warehouse execution, inventory control, serialization processes, and WMS workflows.
Serve as a SME trainer during regulatory inspections (FDA, DEA, Board of Pharmacy), customer audits, and internal quality audits, with a focus on training compliance across distribution.
Establish training requirements based on change controls, CAPAs, deviations, and investigations.
Assess training impact for WMS updates, serialization changes, and warehouse process modifications.
Deliver training on cGMP, Good Distribution Practices (GDP), warehouse operations, serialization, and Manhattan Active WMS.
Conduct onboarding training for warehouse personnel.
Partner with Quality, Inventory Control, DSCSA, facilities, IT, and Warehouse Operations at a minimum to maintain curriculum.
Integrate WMS and serialization training into role-based curriculum.
Serve as LMS system owner.
Support integration of WMS and serialization training content.
Develop SOP-based and system-based training materials.
Provide documentation during audits and inspections.
Prepare training metrics and identify gaps.
Support system upgrades as required.
Support training compliance across pharmaceutical distribution facilities.
Participate in safety and warehouse training programs.
Ensure compliance with FDA, DEA, State guidelines and any other relevant requirements.
Perform other duties as assigned.