Training Coordinator

Premier Staffing Solution • Whitestow, IN

2d

About The Position

The Training Coordinator IV oversees and continuously improves training programs in a regulated pharmaceutical warehouse and distribution environment. The role develops, coordinates, and maintains compliant training programs for pharmaceutical storage and distribution, cleanroom operations, laboratory testing, and sampling. It works with Quality, Operations, Laboratory, and Environmental Health & Safety teams to ensure employees are trained, qualified, and compliant with applicable regulatory standards.

The position develops training curricula, role-based matrices, qualification programs, and competency assessments; coordinates onboarding and continuing training; and supports training aligned with cGMP/GDP, FDA, 21 CFR, USP, SOPs, quality standards, and safety requirements. It administers LMS and QMS training records, monitors completion and qualification status, prepares compliance reporting, and develops training materials and improvement plans. The coordinator also provides technical guidance to trainers and colleagues, facilitates training, and supports audits, investigations, corrective actions, and regulatory readiness.

Work takes place in office, warehouse, cleanroom, sampling, and laboratory support environments. The role may involve temperature-controlled or access-restricted areas, PPE and gowning requirements, walking through warehouse and laboratory areas, training observations, supporting activities across multiple shifts, and occasional travel or remote support for additional facilities.

Requirements

• At least 5 years of progressive experience in training, learning and development, pharmaceutical quality, laboratory operations, cleanroom operations, regulated warehouse operations, or a related GxP environment is preferred.
• Strong working knowledge of cGMP/GDP, FDA regulations, 21 CFR, USP requirements, and pharmaceutical quality systems.
• Strong understanding of pharmaceutical regulatory compliance and training requirements.
• Advanced proficiency in Microsoft Office, particularly Excel, with experience in reporting, data analysis, and training metrics.
• Excellent organizational skills and exceptional attention to detail.
• Strong technical writing, documentation, and training development abilities.
• Ability to interpret 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.
• Ability to communicate effectively with employees, technical personnel, and senior leadership.
• Must be able to comply with applicable PPE, gowning, hygiene, and safety requirements.

Nice To Haves

• Bachelor's degree in Life Sciences, Microbiology, Chemistry, Pharmaceutical Sciences, Laboratory Science, Quality, Education, or a related field is strongly preferred.
• Experience in pharmaceutical, biotechnology, laboratory testing, cleanroom, quality assurance, quality control, or regulated distribution environments.
• Experience administering LMS/QMS platforms, managing training records, and developing role-based training programs.
• 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.
• Experience supporting regulatory audits, deviations, corrective actions, change controls, and compliance investigations.
• Certifications in GMP, data integrity, laboratory safety, Train-the-Trainer, OSHA, HazMat, or related disciplines.

Responsibilities

• Develop, implement, and maintain 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.
• Align training assignments with job responsibilities, approved procedures, and regulatory requirements.
• Collaborate with cross-functional teams to identify training needs and improve training effectiveness.
• Develop and coordinate training aligned with cGMP/GDP, FDA, 21 CFR, USP, and applicable regulatory standards.
• Support training on cleanroom behavior, gowning, contamination control, sample handling, laboratory documentation, Good Documentation Practices, data integrity, and ALCOA+ principles.
• Maintain training compliance with SOPs, quality standards, and applicable safety requirements; support training related to deviations, corrective actions, change controls, and regulatory updates.
• Administer and maintain training records in LMS and QMS platforms; manage assignments, matrices, qualification records, and completion tracking.
• Ensure training documentation is accurate, complete, current, and audit-ready; monitor overdue training, certification renewals, and 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 in partnership with subject matter experts.
• Conduct training needs assessments and gap analyses, develop corrective training plans, and evaluate training effectiveness.
• Support continuous improvement initiatives that 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 on 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 corrective actions.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior