Operations Training Specialist I

3 weeks ago

Wilmington, United States Alkermes, Inc. Full time

*This position is located in Wilmington, Ohio

POSITION SUMMARY:

This position ensures the Wilmington site has the support and tools that are needed for departmental training. Compliance with all GxP standards, data integrity regulations and quality culture mindset are at the forefront of all tasks performed. Support departments to develop, revise and maintain curricula for all employees at Wilmington site. Enter all Wilmington training completions into ComplianceWire. Provide continual guidance to area trainers, 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, inspection preparation, Train the Trainer Program, New Employee Training, Periodic Review, Annual Curriculum Review, Lunch and Learn program and annual GxP refresher training. This position assists in the development of training programs, instructor led training and CBT creation. Responsible for administering and assisting new team members with on-boarding and training within their assigned departments, as needed.

MAJOR RESPONSIBILITIES:

  • Interact with management and trainers to develop an understanding of training needs and concerns
  • Identify opportunities to improve training programs
  • Enter training completions into LMS
  • Assist in periodic review of training programs to ensure accuracy and alignment
  • Trend training metrics and provide data to management
  • Assist in curriculum review of employee training to ensure compliance to job curricula
  • Assist in developing, collecting, maintaining, and providing training key performance indicators (KPI's) and metrics data analysis to support continuous improvement and manufacturing training
  • Support creating and updating curricula for positions as needed
  • Revise LMS user groups and curricula as appropriate to maintain training structure and assignments
  • Coordinate the development, implementation, and revision of training programs
  • Create and revise computer-based training (CBT)
  • Utilize Recording Studio to create videos and voice overs
  • Ability to flex to various shifts as needed to support training needs of all employees on their designated shifts
  • Conducts training class for new hires in manufacturing and other areas as requested

QUALIFICATIONS

SKILLS/ABILITIES:

  • Working knowledge of GxP's
  • Quality focused
  • Excellent customer service skills
  • 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
  • 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
  • Ability to mentor newly hired and progressively qualifying personnel; team player committed to Quality
  • Works well in a team environment
  • Responds quickly to assignments
  • Readily adapts to changing job duties
  • Manages time well; ability to multi-task and prioritize
  • Positive attitude
  • Effective listening and communication skills, written and verbal

EDUCATION AND EXPERIENCE

  • Bachelor's degree preferred
  • 1-3+ years of experience in pharmaceutical operations, medical environment or equivalent
PDN-9bc94e9c-b49e-4b84-99ed-f7700f1cb8af

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