Senior Training Specialist

Role Summary

The Senior Training Specialist fosters a culture of learning and compliance, maintains training records, and drives the development of effective training programs for employees and contractors. They work with cross-functional teams to translate regulatory requirements into engaging learning experiences, maintain curricula, and support audits to strengthen quality standards across the organization.

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.

Additional Responsibilities

• Follows all organizational systems, programs, training, policies, and procedures as required and complies with relevant legal mandates. Seeks guidance as necessary.
• Actively supports and participates in the safety program, by reading and abiding by all requirements in the Injury and Illness Prevention Program (I2P2).
• Carries out all responsibilities in an honest, ethical, and professional manner.
• Handles various other duties as delegated by direct supervisor/management.

Qualifications

• Education: Bachelors Degree (BA/BS) - Required
• Experience: 3 years or more 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 verbal and written communication skills.
• Results-driven with strong planning, organizational skills, and attention to detail.
• Strong analytical, critical thinking, and problem-solving skills.
• Innovative problem-solver capable of generating workable solutions.

Education

• Bachelors Degree (BA/BS) - Required

Additional Requirements

• Experience with learning management systems (LMS) and e-Learning programs is implied by responsibilities but not explicitly required beyond the role description.