Senior Training Specialist

Amneal•Brookhaven, NY

About The Position

Position ensures the integrity and correctness of training record entries and security and maintenance of electronic and/or hardcopy records for Amneal's employees and contractors. The Training Specialist is responsible to evaluate change controls, CAPAs and investigations and assess for training needs. Training Specialist prepares and issues training materials and monitors participation. The specialist is responsible for the creation and maintenance of training curricula and work with the cross functional teams across the site. The Training Specialist supports quality unit with preparation of training metrics and training materials. The position is responsible for imparting various cGMP training (i.e. Classroom /online) to all the employees. The position is also responsible for creating training plans for new or revised SOP and ensures that SOPs are made effective only after completion of the required training. This position serves as a key auditee during internal, customer or regulator inspections over training Compliance. Develop training modules using various GMP Guidance and imparting the training as required.Training Specialist oversees work performed by SETE training staff for data entry, support sites with FDA/vendor audits as well as coordinates with IT for support with electronic program (LMS) implementation, data migration and management. The Training Specialist will act as process owner for Amneal adopted learning management system (LMS).

Responsibilities

Establishes training needs based on change control, CAPAs and Investigations.
Identifies required personnel based on curricula and circulates training materials accordingly.
Recommendations expansion to scope, if needed, to ensure accurate participation.
Provide New Hire cGMP Training and Annual cGMP training to all site staff, utilizing the pre-developed training materials provided by Global Quality.
Coordinates with Functional Heads across all departments with updating and maintaining curricula.
Support the Amneal university program/learning management system maintenance from a site perspective
Prepares training materials, maintain supplies and equipment
Support Agency and internal audits by providing requested documentation
Collaborate with IT with data migration and act as system owner for Amneal's learning management system
Supports preparation of metrics respective to training for Quality Review Board (QRB)
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, both for self-protection and the protection of other employees, 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.