Senior Training Specialist

Role Summary

The Senior Training Specialist drives learning and compliance programs, ensuring accuracy and security of training records while translating regulatory requirements into effective training for employees and contractors. The role collaborates with cross-functional teams to maintain curricula, support audits, and strengthen quality standards, empowering professional growth and making training a meaningful part of every employee’s journey. Schedule: 1st Shift 9am - 5:30pm Monday to Friday.

Responsibilities

• Evaluate change controls, CAPAs, and investigations to identify training needs.
• Develop training plans for new or revised SOPs; ensure SOPs are effective only after required training.
• Prepare, issue, and monitor training materials and curricula; maintain supplies and equipment.
• Deliver cGMP training (New Hire, Annual, classroom, and online) using Global Quality–approved materials.
• Collaborate with functional heads and cross-functional teams to update and maintain curricula.
• Create training modules using GMP guidance and deliver as required.
• Support the Quality Unit with training metrics, including preparation for Quality Review Board (QRB).
• Serve as key auditee during internal, customer, and regulatory inspections; provide requested documentation.
• Oversee SETE training staff for data entry and audit support.
• Coordinate with IT on LMS implementation, data migration, and management.
• Act as process owner for Amneal’s learning management system (LMS) and support Amneal University program.

Qualifications

• Bachelors Degree (BA/BS) - Required
• 3 years or more of experience in GxP training, Quality Assurance, or related pharmaceutical/biotech roles

Skills

• Advanced proficiency in Microsoft Office Suite; Office 365 experience preferred.
• Knowledge of compliance and audit requirements.
• Ability to conduct research and apply relevant information to training programs that support organizational effectiveness.
• Ability to work in a fast-paced environment and thrive with ambiguity.
• Ability to meet tight deadlines and effectively prioritize and juggle multiple concurrent projects.
• Strong work ethic and a positive attitude; excellent communication skills, both verbal and written.
• Results-driven with strong planning, organizational skills, and high attention to detail.
• Strong analytical, critical thinking, and problem-solving abilities; innovative in generating workable solutions.
• Specialized knowledge of Microsoft Office programs; experience with an e-Learning program a plus.

Education

• Bachelors Degree (BA/BS) - Required

Additional Requirements

• Follows organizational systems, policies, and procedures and complies with relevant legal mandates.
• Supports and participates in the safety program as required.
• Handles other duties as delegated by direct supervisor/management.