QA Specialist I - Training

PCI Pharma ServicesMadison, WI
105d

About The Position

As a Training Specialist at PCI, you will play a critical role in strengthening the training program across aseptic and non-aseptic manufacturing operations. Your primary responsibility will be to ensure that our teams possess the knowledge, skills, and confidence necessary to perform at their best. This includes delivering On-the-Job Training (OJT) to operators and functional teams, developing and maintaining engaging training materials, facilitating instructor-led training on GMP and technical skills, and partnering with cross-functional leaders to assess training needs and design effective learning solutions. You will also track qualifications, generate training reports, and ensure compliance through our eQMS (Master Control), while keeping training programs updated with process improvements, new SOPs, and quality events.

Requirements

  • 5–10 years in a GMP-regulated pharmaceutical, biotech, or medical device environment (aseptic manufacturing preferred).
  • Hands-on knowledge of aseptic practices—gowning, formulation, fill/finish.
  • Experience creating and delivering training materials, including OJT and e-learning.
  • Strong communication skills—you can present confidently to individuals or large groups.
  • Proficiency in MS Office and familiarity with eQMS/LMS platforms (Master Control experience a plus).
  • A track record of working effectively in cross-functional teams and managing multiple priorities.

Nice To Haves

  • Experience in adult education or pharmaceutical processing.
  • Equivalent industry experience in a related field.

Responsibilities

  • Deliver On-the-Job Training (OJT) to operators and functional teams, mentoring them toward confident, compliant performance.
  • Develop and maintain engaging training materials—checklists, job aids, qualifications, e-learning modules, and more.
  • Facilitate instructor-led training on GMP, technical skills, and functional topics.
  • Partner with cross-functional leaders to assess training needs and design effective learning solutions.
  • Track qualifications, generate training reports, and ensure compliance through our eQMS (Master Control).
  • Keep training programs up to date with process improvements, new SOPs, and quality events.
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