GMP Training Specialist

Paragon Bioservices   •  

Baltimore, MD

5 - 7 years

Posted 237 days ago

This job is no longer available.

Key Responsibilities include but are not limited to: 

  • Manage the Training and Tracking System, ensuring Pre-Clinical and GMP personnel are appropriately and adequately trained to perform their assigned function to a high level of competence, regulatory compliance and efficiency.
  • Provide oversight of the training program and system.
  • Work directly with all levels and departments at Paragon to establish training curriculum and assignments based on assigned functions.
  • Develop and deliver training presentations on pertinent topics to large groups of personnel on an as needed basis, including new employee orientation, annual refresher training, remedial training and on as a needed basis to support the production schedule. Examples include current Good Manufacturing Practices (cGMPs), Good Documentation Practices (GDPs), Aseptic Processing, Client Confidentiality Training.
  • Process and maintain file system for training records.
  • Ensure critical procedures have appropriate mechanisms to demonstrate comprehension and understanding. The Training Coordinator will work with applicable functions to assist in development of technical training materials.
  • Maintain system to track required training and qualifications
  • Ensure the timely and accurate retrieval of personnel training and qualifications.
  • Liaison with Document Control and other functional departments to coordinate training on new or revised procedures.
  • Evaluate, develop and implement improvements to current training tracking system.
  • Lead the evaluation and selection of a 21 CFR Part 11 compliant learning management system. Manage the site implementation of the selected learning management system.
  • Work with clients and Project Management to support the success of manufacturing campaigns as needed
  • Maintain databases and systems used for tracking various GMP manufacturing associated support activities
  • Assist with the generation and/or revision of GMP documentation such as standard operating procedures
  • Support regulatory (FDA, EMA) and client audits/inspections of Paragon
  • Assist with performing internal audits
  • Work closely with Manufacturing, Facilities and Quality Control staff to resolve quality issues
  • Continually evaluate systems and procedures for improvement for efficiency while ensuring compliance to applicable regulatory requirements and standards
  • Familiarity with current Good Manufacturing Practices (cGMPs) and 21 CFR Parts 210 and 211 OR Quality System regulations (QSR) per 21 CFR Part 820
  • Exposure to applicable biological regulations (21 CFR Part 600s) OR European GMPs (Eudralex), a plus
  • Familiarity with training systems within a cGMP environment, including developing training materials, directly training personnel, or working with facility training tracking programs.
  • Familiarity with the FDA, MHRA and EMA Data Integrity Guidelines

 Experience & Education:

  • Bachelor degree in a Life Sciences discipline
  • 6 years of experience within the biologic, pharmaceutical or medical device industry with responsibilities for developing or delivering training to colleagues and/or managing a training program.
  • Familiarity with current Good Manufacturing Practices (cGMPs) and 21 CFR 210/211
  • Familiarity with electronic systems, including Microsoft Access and Excel
  • Have the knowledge, and ability to apply basic scientific and regulatory principles utilized to solve operational, as well as routine quality tasks
  • Understanding of biological manufacturing processes for microbial, cell culture or viral including cell/virus banking, upstream/downstream Bulk Drug Substance (BDS) production or Aseptic Filling a plus.
  • Familiarity with aseptic gowning practices and aseptic techniques a plus.
  • Ability to quickly learn and navigate new electronic systems
  • Ability to comfortably speak in front of large audiences
  • Able to work in a team setting and independently under minimum supervision
  • Experience supporting Federal government contracts is a plus