Amneal Pharmaceuticals LLC (J0P) in
Senior Training Specialist
Amneal Pharmaceuticals LLC (J0P) in, Shirley, New York, United States
Overview
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).
Schedule 1st Shift 9am - 5:30pm Monday to Friday
Essential Functions
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)
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, 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.
Education
Bachelors Degree (BA/BS) - Required
Experience
3 years or more in experience in GxP training, Quality Assurance, or related pharmaceutical/biotech roles
Skills
Advanced proficiency in Microsoft Office Suite. Office 365 experience preferred. - Proficient
Knowledge of compliance and audit requirements. - Proficient
Ability to conduct research and apply relevant information to training programs that support organizational effectiveness. - Proficient
Must be able to work in a fast-paced environment and thrive with ambiguity. - Proficient
Ability to meet tight deadlines and effectively prioritize and juggle multiple concurrent projects - Proficient
Must have a strong work ethic and a positive attitude. - Proficient
Excellent communication skills, both verbal and written. - Proficient
Results-driven achiever with exemplary planning and organizational skills, along with a high attention to detail. - Proficient
Strong assessment, analytical, critical thinking, and problem-solving skills. - Proficient
Innovative problem-solver who can generate workable solutions and address needs. - Proficient
Specialized Knowledge
Comprehensive knowledge of Microsoft Office programs Experience with an e-Learning computer program a plus
Additional Requirement This position requires successful completion of an OSHA-compliant Respirator Fit Test.
Compensation The base salary for this position ranges from $100,000 to $115,000 per year. Amneal ranges reflect the Company\'s good faith estimate of base salary that Amneal reasonably believes that it will pay for said position at the time of the posting. Individual compensation will ultimately be determined based on a variety of relevant factors, including but not limited to, qualifications, geographic location and other relevant skills. At the heart of our Total Rewards commitment is a comprehensive, flexible and competitive benefits program for eligible positions that enables you to choose the plans and coverage that meet your personal needs. This includes above-market, diverse and robust health and insurance benefits to meet the varied needs of our employees as well as a significant 401(k) matching contribution to help our employees save for retirement. We also promote employee well-being with programs that helps you enjoy your career alongside life\'s many other commitments and opportunities.
Amneal is an Equal Opportunity Employer that does not discriminate on the basis of sex, age, race, color, creed, religion, national origin, sexual orientation, gender identity, genetic information, disability, veteran status, liability for service in the U.S. Armed Forces or any other characteristic protected by applicable federal, state, or local laws.
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Schedule 1st Shift 9am - 5:30pm Monday to Friday
Essential Functions
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)
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, 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.
Education
Bachelors Degree (BA/BS) - Required
Experience
3 years or more in experience in GxP training, Quality Assurance, or related pharmaceutical/biotech roles
Skills
Advanced proficiency in Microsoft Office Suite. Office 365 experience preferred. - Proficient
Knowledge of compliance and audit requirements. - Proficient
Ability to conduct research and apply relevant information to training programs that support organizational effectiveness. - Proficient
Must be able to work in a fast-paced environment and thrive with ambiguity. - Proficient
Ability to meet tight deadlines and effectively prioritize and juggle multiple concurrent projects - Proficient
Must have a strong work ethic and a positive attitude. - Proficient
Excellent communication skills, both verbal and written. - Proficient
Results-driven achiever with exemplary planning and organizational skills, along with a high attention to detail. - Proficient
Strong assessment, analytical, critical thinking, and problem-solving skills. - Proficient
Innovative problem-solver who can generate workable solutions and address needs. - Proficient
Specialized Knowledge
Comprehensive knowledge of Microsoft Office programs Experience with an e-Learning computer program a plus
Additional Requirement This position requires successful completion of an OSHA-compliant Respirator Fit Test.
Compensation The base salary for this position ranges from $100,000 to $115,000 per year. Amneal ranges reflect the Company\'s good faith estimate of base salary that Amneal reasonably believes that it will pay for said position at the time of the posting. Individual compensation will ultimately be determined based on a variety of relevant factors, including but not limited to, qualifications, geographic location and other relevant skills. At the heart of our Total Rewards commitment is a comprehensive, flexible and competitive benefits program for eligible positions that enables you to choose the plans and coverage that meet your personal needs. This includes above-market, diverse and robust health and insurance benefits to meet the varied needs of our employees as well as a significant 401(k) matching contribution to help our employees save for retirement. We also promote employee well-being with programs that helps you enjoy your career alongside life\'s many other commitments and opportunities.
Amneal is an Equal Opportunity Employer that does not discriminate on the basis of sex, age, race, color, creed, religion, national origin, sexual orientation, gender identity, genetic information, disability, veteran status, liability for service in the U.S. Armed Forces or any other characteristic protected by applicable federal, state, or local laws.
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