Training Coordinator -Pharmaceutical / GMP

Premier Staffing Solution; Whitestown (IN); On-site; USD 70,000 - 100,000; Full time

Job summary

Premier Staffing Solution, LLC is seeking an experienced Training Coordinator IV to develop and manage comprehensive training programs in a regulated pharmaceutical warehouse and distribution setting. The role ensures staff are trained and qualified per cGMP/GDP and FDA regulations, with collaboration across Quality, Operations, Laboratory, and EHS teams.

The coordinator will create curricula, maintain training matrices, manage onboarding and refresher courses, and administer training records in

Qualifications

• 5+ years in training, learning & development or regulated environments.
• Experience in pharmaceutical/biotech operations and quality systems.
• Experience administering LMS/QMS platforms and managing training records.
• Familiarity with cGMP/GDP, FDA 21 CFR, USP and related SOPs.

Responsibilities

• Develop, implement, and maintain training programs for warehouse, cleanroom, sampling, and lab operations.
• Create training matrices, curricula, qualification programs, and competency assessments.
• Coordinate onboarding, refresher courses, and required certifications.
• Maintain training records in LMS/QMS and track completions, overdue training, and qualifications.
• Support audits, deviations, CAPAs, and change controls.
• Partner with SMEs and cross-functional teams to improve training effectiveness.
• Develop training materials, job aids, and competency assessments.

Skills

Training program development

LMS administration

Regulatory compliance

Data analysis

Documentation

Education

Bachelor's degree in Life Sciences/Quality/Pharma

Tools

LMS/QMS platforms

Microsoft Office (Excel)

Job description

We are seeking an experienced Training Coordinator IV to develop, coordinate, and maintain training programs within a regulated pharmaceutical warehouse and distribution environment.

This role is responsible for ensuring employees are properly trained and qualified in accordance with cGMP/GDP, FDA regulations, and company procedures. The ideal candidate will have experience in pharmaceutical or biotechnology operations, training program development, regulatory compliance, and Learning Management Systems (LMS).

The Training Coordinator will work closely with Quality, Operations, Laboratory, and EHS teams to maintain training compliance, improve employee competency, and support audit readiness.

Key Responsibilities

• Develop, implement, and maintain training programs for pharmaceutical warehouse, cleanroom, sampling, and laboratory operations.
• Create and manage training matrices, role-specific curricula, qualification programs, and competency assessments.
• Coordinate employee onboarding, ongoing training, refresher courses, and required certifications.
• Ensure training programs align with cGMP/GDP, FDA, 21 CFR, USP, SOPs, and applicable regulatory requirements.
• Support training related to cleanroom procedures, gowning, contamination control, sample handling, Good Documentation Practices, and data integrity.
• Administer and maintain training records within LMS/QMS platforms, tracking assignments, completions, overdue training, and qualifications.
• Develop training materials, work instructions, job aids, and competency assessments.
• Identify training gaps, conduct needs assessments, and implement corrective training and process improvements.
• Partner with subject matter experts and cross-functional teams to improve training effectiveness.
• Support internal audits, client audits, regulatory inspections, deviations, corrective actions, and change controls.
• Provide guidance and mentoring to trainers, supervisors, and subject matter experts.
• Develop training reports, compliance metrics, and documentation for leadership review.

Qualifications & Experience

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

Key Skills

• Strong organizational skills and exceptional attention to detail.
• Excellent communication, technical writing, and training development abilities.
• Ability to interpret regulatory requirements and translate them into effective training programs.
• Strong analytical, problem-solving, and critical-thinking skills.
• Ability to manage multiple priorities in a fast-paced, regulated environment.
• Experience mentoring, coaching, and collaborating with cross-functional teams.
• Work across office, warehouse, cleanroom, sampling, and laboratory support environments.
• Must comply with applicable PPE, gowning, hygiene, and safety requirements.
• Position may require walking through warehouse and laboratory areas and supporting multiple shifts.
• Occasional travel or remote support for additional facilities may be required.