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.
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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.
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