GMP Training Specialist

Job Description

Job Description

POSITION SUMMARY :

The GMP Training Specialis t is responsible for developing, implementing, and maintaining a robust GMP training program to ensure compliance with regulatory requirements and internal quality standards. This role oversees the Learning Management System (LMS), builds and maintains curricula, coordinates onboarding and qualification activities, and partners with SMEs to deliver effective training across the organization. The Training Specialist plays a key role in inspection readiness by ensuring accurate training records, compliance tracking, and continuous improvement of the training system.

PRIMARY RESPONSIBILITIES :

• Develop and maintain site training procedures, ensuring alignment with global and regulatory requirements (e.g., 21 CFR Part 211, Part 11, EU GMP Annex 1).
• Build and maintain role-based curricula and a sitewide training matrix (GxP + job / area specific).
• Administer the LMS (initially Dot Compliance eQMS training module; interim tooling as needed); manage records, assignments, retraining, and metrics.
• Develop and deliver training content (SOPs / work instructions, onboarding, GMP basics, data integrity, deviation / CAPA effectiveness, change control).
• Coordinate and document OJT / qualification, including aseptic gowning and cleanroom behavior; support media-fill / readiness training with QA / Operations.
• Track training compliance; produce dashboards for inspections / audits; close training CAPAs and effectiveness checks.
• Partner with SMEs to schedule / proctor proficiency / qualification testing; maintain trainer qualifications.
• Lead training-related responses during audits / inspections, ensuring timely closure of commitments.
• Continuously assess training effectiveness and propose improvements to ensure knowledge retention and GMP compliance.
• Facilitate engaging training sessions and workshops to reinforce GMP principles and quality culture.
• Own sitewide training compliance reporting, ensuring data accuracy and readiness for client and regulatory inspections.

QUALIFICATIONS & REQUIREMENTS :

) and aseptic processing preferred.

THE FINE PRINT :

The salary range in Minnesota is $75,000 to 90,000 per year. Please note that compensation may vary outside of this range depending on several factors, including but not limited to a candidate’s qualifications, skills, competencies, experience, and location.

Benefit packages for this role include medical, dental, and vision insurance, as well as a Health Savings Account or Flexible Spending Account options (depending on the plan chosen), and 401k retirement account access with employer matching. Team members in this role are also entitled to paid sick leave and / or other paid time off in compliance with applicable law. Relocation is available to qualified team members.

This job description is a summary of the typical functions of the position, not necessarily an exhaustive or comprehensive list of all possible position responsibilities, tasks, and duties. The company reserves the right to assign or reassign duties and responsibilities to this job at any time. This job does not constitute a written or implied contract of employment; employment remains “at-will”.

Nucleus RadioPharma is an equal opportunity employer and believes everyone deserves respect, dignity, and equality. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran, or disability status.