Training Systems Specialist I

POSITION SUMMARY:

 This position ensures the Wilmington site has the support and tools needed for the appropriate documentation of training into the Learning Management System (LMS), and support of other systems used in the execution of the training functions. Compliance with all GxP standards, data integrity regulations and quality culture mindset are at the forefront of all tasks performed. Supports departments in the development, revision and maintenance of curricula for all employees at Wilmington site. Provide continual guidance to area trainers, subject matter experts (SME), compliance specialists, management, and peers to ensure compliance in training practices and documentation. This position supports a comprehensive training strategy that supports the overall organization. Participate in other quality systems activities such as deviations/CAPA’s, internal and external audits, and inspection preparation. 

MAJOR RESPONSIBILITIES:

• Active member of the Wilmington Training Team
• Actively supports and implements the vision for the systems support of training activities for the Wilmington Site. 
• Is an LMS coordinator for the Training Systems and responsible for daily activities related to:
  • LMS (Training Management Requests, projects, etc.) 
  • Document Management System (DMS) related training tasks 
  • Electronic Executable Document System sending and form completions
  • Deviation and Change Management System training related tasks
  • Audit Support generating reports from the LMS.
• Exeecutes all job duties per Site Work Instructions for LMS duties.
• Supports special projects as needed
• Data Entry Support and processing for LMS activities, including system access forms, training forms, etc.
• Support the Training Metrics development, deliverance and maintenance for the Wilmington Training Team. 
• Ability to flex to various shifts as needed to support training needs of all employees on their designated shifts 

QUALIFICATIONS SKILLS/ABILITIES: 

• Working knowledge of cGMP, GDP, ALCOA+ and GxP’s
• Quality focused 
• Excellent customer service skills
• Critical Thinking Skills to analyze tasks and processes
• Make decisions that align with company policies and objectives considering all available information, weighing the risks and benefits, and choosing the most effective course of action 
• Knowledge of training methodologies and instructional design preferred 
• Knowledge of learning management systems, ComplianceWire preferred 
• Proficiency with Microsoft PC based (Outlook, Excel, Word) software; willingness to learn and use new technology-based tools 

PERSONAL ATTRIBUTES:

• Attention to detail
• Innovative thinker and problem solver 
• Ability to lead teams/groups/meetings/projects 
• Flexible and can embrace change 
• Strong oral and written communication skills 
• Highly organized, efficient worker with good communication skills 
• A motivated, self-starter capable of managing multiple duties and tasks 
• Ability to work independently. Willing to learn new tasks, skills 
• Demonstrates attention to detail and results oriented 
• Works well in a team environment 
• Responds quickly to assignments 
• Readily adapts to changing job duties 
• Readily adapts to a learner’s needs 
• Manages time well; ability to multi-task and prioritize 
• Positive attitude 
• Effective listening and communication skills, written and verbal 

EDUCATION AND EXPERIENCE 

• 4 year Bachelor's degree preferred or 3-5 years of relevant experience 
• 3+ years of experience in pharmaceutical operations, medical environment or equivalent
   

PHYSICAL REQUIREMENTS
• Must be able to work in an office environment.
•The noise level in the work environment is typically low to moderate
•Must be able to sit for prolonged periods of time and work on a computer
•While performing the duties of this job, the employee occasionally lift and/or move up to 25 pounds

Why join Team Alkermes?

Alkermes applies its deep neuroscience expertise to develop medicines designed to help people living with complex and difficult-to-treat psychiatric and neurological disorders. A fully-integrated, global biopharmaceutical company, headquartered in Ireland with U.S. locations in Massachusetts and Ohio, we are committed to pursuing great science, driven by deep compassion to make a real impact in the lives of patients. Alkermes has a portfolio of proprietary commercial products for the treatment of alcohol dependence,