Nucleus RadioPharma
Base pay range: $75,000.00/yr - $90,000.00/yr
Position Summary
The
GMP Training Specialist
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; 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
Bachelor’s degree in Life Sciences, Quality, or related field, or equivalent experience required. 2–4 years of experience in GMP training, quality systems, or related role in pharmaceuticals/biotech required. Hands-on experience with Learning Management Systems (LMS) required. Knowledge of FDA, EU, and USP regulations applicable to radiopharmaceuticals or sterile products required. Strong organizational, communication, and facilitation skills. Experience delivering classroom and OJT training in aseptic or radiopharmaceutical environments preferred. Train-the-Trainer or instructional design certification preferred. Familiarity with radiopharmaceutical GMPs (USP) and aseptic processing preferred. Benefits
Benefit packages for this role include medical, dental, and vision insurance, as well as a Health Savings Account or Flexible Spending Account options, 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. 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.
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The
GMP Training Specialist
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; 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
Bachelor’s degree in Life Sciences, Quality, or related field, or equivalent experience required. 2–4 years of experience in GMP training, quality systems, or related role in pharmaceuticals/biotech required. Hands-on experience with Learning Management Systems (LMS) required. Knowledge of FDA, EU, and USP regulations applicable to radiopharmaceuticals or sterile products required. Strong organizational, communication, and facilitation skills. Experience delivering classroom and OJT training in aseptic or radiopharmaceutical environments preferred. Train-the-Trainer or instructional design certification preferred. Familiarity with radiopharmaceutical GMPs (USP) and aseptic processing preferred. Benefits
Benefit packages for this role include medical, dental, and vision insurance, as well as a Health Savings Account or Flexible Spending Account options, 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. 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.
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