Training Coordinator IV - Pharmaceutical / GMP

Position Overview

Key Responsibilities

• Develop, implement, and maintain comprehensive training programs for pharmaceutical warehouse, cleanroom, sampling, and laboratory operations.
• Create and manage role-specific training matrices, curricula, qualification programs, and competency assessments.
• Coordinate employee onboarding, ongoing training, refresher courses, and qualification requirements.
• Ensure training assignments align with job responsibilities, approved procedures, and regulatory requirements.
• Collaborate with cross-functional teams to identify training needs and improve overall training effectiveness.

• Develop and coordinate training programs aligned with cGMP/GDP, FDA, 21 CFR, USP, and applicable regulatory standards.
• Support training related to cleanroom behavior, gowning procedures, contamination control, sample handling, and laboratory documentation.
• Ensure employees understand Good Documentation Practices, data integrity requirements, and ALCOA+ principles.
• Maintain training compliance with standard operating procedures (SOPs), quality standards, and applicable safety requirements.
• Support training initiatives related to deviations, corrective actions, change controls, and regulatory updates.

• Administer and maintain training records within Learning Management Systems (LMS) and Quality Management Systems (QMS).
• Manage course assignments, training matrices, qualification records, and completion tracking.
• Ensure training documentation is accurate, complete, current, and audit-ready.
• Monitor overdue training, certification renewals, and employee qualification requirements.
• Assist with LMS/QMS enhancements, system updates, and process improvements.
• Develop training reports, dashboards, and compliance metrics for leadership review.

• Develop technical training materials, SOP summaries, job aids, work instructions, checklists, and competency assessments.
• Partner with subject matter experts to ensure training materials reflect current procedures and regulatory requirements.
• Conduct training needs assessments and gap analyses to identify opportunities for improvement.
• Develop corrective training plans and evaluate training effectiveness.
• Support continuous improvement initiatives to strengthen employee competency, operational consistency, and compliance.

• Provide technical guidance, mentoring, and coaching to trainers, Training Coordinators, supervisors, and subject matter experts.
• Facilitate training sessions, workshops, and Train-the-Trainer programs.
• Collaborate with Quality, Operations, Laboratory, and EHS teams to support training and compliance initiatives.
• Prepare and present training documentation during internal audits, client audits, and regulatory inspections.
• Assist with audit findings, corrective actions, investigations, and regulatory readiness activities.
• Identify and escalate training-related compliance risks and recommend appropriate corrective actions.

Qualifications & Experience

• 5+ years of progressive experience in training, learning and development, pharmaceutical quality, laboratory operations, cleanroom operations, regulated warehouse operations, or a related GxP environment preferred.
• Bachelor's degree in Life Sciences, Microbiology, Chemistry, Pharmaceutical Sciences, Laboratory Science, Quality, Education, or a related field strongly preferred.
• Experience working within pharmaceutical, biotechnology, laboratory testing, cleanroom, quality assurance, quality control, or regulated distribution environments strongly preferred.
• Strong working knowledge of cGMP/GDP, FDA regulations, 21 CFR, USP requirements, and pharmaceutical quality systems.
• Experience administering LMS/QMS platforms, managing training records, and developing role-based training programs preferred.
• Familiarity with cleanroom gowning, contamination control, sampling procedures, laboratory documentation, and data integrity requirements.
• Experience developing SOPs, training materials, technical documentation, competency assessments, and qualification checklists preferred.
• Experience supporting regulatory audits, deviations, corrective actions, change controls, and compliance investigations preferred.
• Advanced proficiency in Microsoft Office, particularly Excel, with experience in reporting, data analysis, and training metrics.
• Relevant certifications in GMP, data integrity, laboratory safety, Train-the-Trainer, OSHA, HazMat, or related disciplines are a plus.

Key Skills & Competencies

• Strong understanding of pharmaceutical regulatory compliance and training requirements.
• Excellent organizational skills with exceptional attention to detail.
• Strong technical writing, documentation, and training development abilities.
• Ability to interpret complex regulatory requirements and translate them into effective training programs.
• Excellent written and verbal communication skills.
• Strong analytical, problem-solving, and critical-thinking abilities.
• Ability to manage multiple priorities and deadlines in a fast-paced, regulated environment.
• Demonstrated ability to mentor, coach, and collaborate with cross-functional teams.
• Experience identifying training gaps and implementing process improvements.
• Ability to communicate effectively with employees, technical personnel, and senior leadership.

Work Environment

• Work is performed in office, warehouse, cleanroom, sampling, and laboratory support environments.
• May require working in temperature-controlled or access-restricted areas.
• Must be able to comply with applicable PPE, gowning, hygiene, and safety requirements.
• Position may require walking through warehouse and laboratory areas, conducting training observations, and supporting activities across multiple shifts.
• Occasional travel or remote support for additional facilities may be required.

Equal Employment Opportunity