Training Coordinator

Technology Transfer Services; Whitestown (IN); Sur place; USD 85 000 - 120 000; Plein temps

Résumé du poste

Technology Transfer Services seeks an experienced Training Coordinator IV to oversee and improve training programs in a regulated pharmaceutical warehouse and distribution setting.

The role focuses on developing, coordinating, and maintaining compliant training for storage, cleanroom operations, sampling, and lab testing, with close collaboration across Quality, Operations, Laboratory, and EHS teams.

Qualifications

• Minimum 5+ years in training and development in pharmaceutical quality.
• Bachelor's degree in Life Sciences or related field.
• Experience in pharma, biotech, lab testing, or regulated distribution.
• Strong knowledge of cGMP/GDP, FDA, 21 CFR, USP.
• Experience administering LMS/QMS and developing role-based programs.
• Proficiency in Excel, data analysis, and training metrics.

Responsabilités

• Develop, implement, and maintain comprehensive training programs for pharma warehouse, cleanroom, sampling, and laboratory operations.
• Create and manage role-specific training matrices, curricula, qualification programs, and competency assessments.
• Coordinate onboarding, ongoing training, refresher courses, and qualification requirements.
• Ensure training assignments align with job responsibilities, SOPs, and regulatory requirements.
• Collaborate with cross-functional teams to identify training needs and improve training effectiveness.
• Develop and coordinate training programs aligned with cGMP/GDP, FDA, 21 CFR, USP, and regulatory standards.
• Maintain training records within LMS and QMS, manage course assignments and completion tracking.
• Develop training reports, dashboards, and compliance metrics for leadership review.
• Develop technical training materials, SOP summaries, job aids, and competency assessments.
• Partner with subject matter experts to 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 to strengthen employee competency and compliance.
• Prepare and present training documentation during audits and inspections.

Connaissances

Training program development

LMS administration

Regulatory compliance

GxP knowledge

Documentation

Cross-functional collaboration

Quality systems

Formation

Bachelor's degree in Life Sciences or related field

Outils

LMS/QMS platforms

Description du poste

Training Coordinator IV – Pharmaceutical / GMP

Position Overview

We are seeking an experienced and highly detail-orientedTraining Coordinator IV to oversee and continuously improve training programs within a regulated pharmaceutical warehouse and distribution environment.

This advanced-level position focuses on developing, coordinating, and maintaining compliant training programs supporting pharmaceutical storage, distribution, cleanroom operations, laboratory testing, and sampling activities.

The ideal candidate will have a strong background in pharmaceutical or biotechnology operations, cGMP/GDP compliance, training program development, and Learning Management Systems (LMS). This individual will collaborate closely with Quality, Operations, Laboratory, and Environmental Health & Safety (EHS) teams to ensure employees are properly trained, qualified, and compliant with applicable regulatory standards.

Key Responsibilities

Training Program Development & Coordination

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.

Pharmaceutical Compliance & Regulatory Training

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.

Learning Management Systems & Documentation

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.

Leadership, Collaboration & Audit Support

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 elevate training-related compliance risks and recommend appropriate corrective actions.

Job Requirements

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.

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 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.

We are an Equal Opportunity Employer committed to providing equal employment opportunities to all qualified applicants without regard to race, color, religion, sex, national origin, age, disability, veteran status, or any other legally protected characteristic.