Senior Training Specialist

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).

Responsibilities

* The Senior Training Specialist evaluates change controls, CAPAs, deviations, and investigations to determine training impacts across the distribution environment. The role develops and deploys training programs that ensure operational readiness for warehouse execution, inventory control, serialization processes, and WMS workflows.

* This position serves 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.

* Training Strategy & Compliance:
Establish training requirements based on change controls, CAPAs, deviations, and investigations. Assess training impact for WMS updates, serialization changes, and warehouse process modifications.

* cGMP, GDP & Distribution Training Delivery:
Deliver training on cGMP, Good Distribution Practices (GDP), warehouse operations, serialization, and Manhattan Active WMS. Conduct onboarding training for warehouse personnel.

* Curriculum Management:
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.

* LMS Ownership & System Integration:
Serve as LMS system owner. Support integration of WMS and serialization training content.

* Training Material Development:
Develop SOP-based and system-based training materials.

* Audit & Inspection Support:
Provide documentation during audits and inspections

* Metrics & Continuous Improvement:
Prepare training metrics and identify gaps.

* System & Process Ownership:
Support system upgrades as required.

Additional Responsibilities:

* 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.