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Training Operations Specialist

2 months ago

Wilmington, Delaware, United States Alkermes Full time

Position Overview:

The Training Operations Specialist role at Alkermes focuses on delivering administrative and operational assistance for compliance training via the learning management system (LMS).

Key Responsibilities:

  • Oversee the administration of the LMS, Docusign platform, and organization of training documentation.
  • Address daily compliance training inquiries and generate relevant reports.
  • Collaborate with subject matter experts (SMEs) across various departments to allocate curricula and training modules within the LMS.
  • Provide support and guidance to SMEs regarding training systems and procedures.
  • Facilitate vendor-supplied compliance training while ensuring adherence to established processes.
  • Evaluate and authorize training programs in accordance with predefined templates.
  • Create, modify, and sustain training materials for diverse training sessions.
  • Produce reports from the LMS to track compliance status and fulfill business requests.
  • Analyze training metrics and key performance indicators to evaluate effectiveness.
  • Revise curricula review forms and training manuals as necessary.
  • Assist in audits and regulatory inspections.
  • Champion continuous improvement initiatives.

Skills and Abilities:

  • Proven experience in Pharmaceutical Quality Assurance and resolving compliance challenges.
  • Familiarity with US and European GMP regulations.
  • Strong written and verbal communication skills.
  • Background in quality systems for drug manufacturing and quality control.

Personal Qualities:

  • Collaborative team player dedicated to quality.
  • Detail-oriented and focused on results.
  • Effective communicator and problem-solver.
  • Adaptable to change with the ability to manage multiple tasks efficiently.
  • Proficient in computer skills.
  • Demonstrates a strong work ethic and inspires others.
  • Capable of thriving in a fast-paced environment.
  • Highly organized with a keen attention to detail.
  • Proactive in identifying opportunities for improvement.
  • Provides leadership and development support to colleagues.

Education and Experience:

  • A Bachelor's degree in a scientific discipline or equivalent is required.
  • A minimum of 1 year of experience in Quality Assurance within the pharmaceutical sector is essential.