Training Specialist Location:

Greenfield, IN Position Summary We are seeking an experienced Training Coordinator IV to lead and manage the training program for our regulated pharmaceutical warehouse and laboratory operations. This role ensures employees are properly trained on cGMP, GDP, SOPs, clean room practices, sampling, laboratory procedures , and quality systems while maintaining audit-ready training records. The Training Coordinator partners closely with Quality, Operations, Laboratory, EHS, and site leadership to develop training programs, maintain compliance, and drive continuous improvement. This role is particularly critical to the successful startup and long-term operation of the Mount Comfort site , as it will support a cleanroom environment dedicated to sampling and testing activities. demonstrates strong laboratory experience; and show the level of training program ownership and coordination required for this position. For the Training Coordinator IV role, we need a candidate who brings both relevant laboratory/clean room experience and demonstrated responsibility for establishing, managing, and maintaining a site training program . This includes ownership of training curricula, qualification and competency programs, training records and compliance, and coordination of training requirements within a regulated environment . Key Responsibilities Own and manage the site's training program for regulated warehouse, laboratory, and clean room operations. Develop and maintain training curricula, training matrices, qualification programs, and onboarding plans. Ensure compliance with FDA, c

GMP, GDP, 21

CFR, USP, and company quality requirements. Coordinate new hire training, annual retraining, and employee competency assessments. Maintain accurate training records within the LMS/QMS and ensure audit readiness. Create and update SOP training materials, job aids, work instructions, and learning resources. Partner with Quality and Operations to support deviations, CAPAs, change controls, audits, and inspections. Monitor training compliance and report completion metrics to leadership. Conduct training needs assessments and recommend improvements. Coach site trainers and subject matter experts to ensure consistent training delivery. Support continuous improvement initiatives that strengthen compliance and employee development. Qualifications Bachelor's degree preferred - in Life Sciences, Education, Quality, or a related field or experience in the relevant field 5+ years of training experience in a pharmaceutical, biotech, laboratory, or other regulated GMP environment. Strong understanding of : c

GMP/GDP FDA 21 CFR

SOPs and controlled documentation Training compliance Audit readiness Experience administering an LMS or QMS. Excellent communication, organization, and project management skills. Experience supporting clean room, laboratory, sampling, or pharmaceutical warehouse operations. Experience with MasterControl or similar LMS/QMS systems . Knowledge of data integrity (ALCOA+), CAPA, change control, and deviation investigations. Train-the-Trainer, GMP, OSHA, or related certifications . What You'll Bring Strong leadership and collaboration skills Excellent technical writing and documentation abilities Ability to manage multiple projects in a fast-paced regulated environment Passion for employee development and continuous improvement Detail-oriented with a strong compliance mindset Work Environment This position works in both office and warehouse environments, including regulated clean room and laboratory support areas. Candidates must be comfortable working in GMP environments and following PPE and gowning requirements.

Pay:

$80,000.00 - $90,000.00 per year

Benefits:

401(k) Dental insurance Health insurance Life insurance Paid time off Vision insurance

Experience:

GMP:

5 years (Required)

United States Pharmacopeia Standards :

5 years (Required)

LMS:

5 years (Required) Pharma & Logistics warehouse training: 5 years (Required) Training & development: 5 years (Required)

Work Location:

In person