Training Specialist; Pharmaceutical​/cGMP

Job Title
- Training Specialist Location
- Greenfield, IN (no relocation available and no VISA candidates or C2C/C2H or W2)

The Training Coordinator IV is an advanced-level, site-focused training role responsible for establishing, maintaining, and continuously improving the training program for a regulated warehouse operation that stores pharmaceutical products and performs sampling and testing activities in a clean room and/or laboratory environment This role is responsible for all applicable Training Coordinator III responsibilities, with increased emphasis on pharmaceutical cGMP/GDP expectations, laboratory controls, clean room behavior, contamination control, sample handling, data integrity, and competency-based qualification.

The Training Coordinator IV partners closely with Quality, Operations, Laboratory/Sampling personnel, EHS, site leadership, Corporate Quality, and client stakeholders to translate 21 CFR, USP, client, SOP, and site-specific requirements into effective training matrices, curricula, qualification programs, job aids, assessments, and training effectiveness measures
. This role supports audit and regulatory inspection readiness by ensuring training assignments, records, and competency evidence are accurate, current, controlled, and readily retrievable.

• College degree in life sciences, microbiology, chemistry, pharmaceutical sciences, laboratory science, quality, education/training, or related field strongly preferred.
• 5+ years of progressive experience in training, learning and development, pharmaceutical quality, laboratory operations, clean room operations, regulated warehouse operations
  , or a related GxP environment preferred.
• Direct experience supporting or working in pharmaceutical, biotech, laboratory testing, clean room, sampling, quality control, quality assurance, or regulated distribution environments.
• Demonstrated experience with 21 CFR, cGMP/GDP, USP, data integrity, laboratory documentation
  , controlled documents, training records, audit readiness, or client/regulatory inspection.
• Experience administering LMS/QMS platforms
  , assigning and configuring courses, developing curricula, maintaining training matrices, monitoring completion, and reporting training status to leadership.
• Experience developing technical training materials, job aids, SOPs, work instructions, qualification checklists, assessments, resource guides, workshops, or role-based learning content
• Experience conducting training needs assessments, training gap analyses, OJT verification, competency assessments, training remediation plans, and training effectiveness checks.
• Experience supporting deviations, corrective actions, change controls, audit responses, client requests, regulatory readiness, or continuous improvement projects.
• Clean room gowning qualification, laboratory safety, train-the-trainer, ASQ, GMP, data integrity, OSHA, Haz Mat, DOT/49 CFR, PIT trainer, or similar certifications preferred.

• Advanced knowledge of training program design
  , facilitation, onboarding, adult learning, competency-based qualification,
  LMS/QMS administration
  , training reporting, and training effectiveness evaluation.
• S
  trong working knowledge of pharmaceutical cGMP/GDP expectations, 21 CFR requirements
  , USP concepts, data integrity principles, controlled documentation, quality records, laboratory documentation, and audit-readiness practices.
• Pharmaceutical and laboratory testing background with the ability to understand and translate sampling, clean room, laboratory, and testing requirements into practical training and qualification programs.
• Knowledge of clean room behavior
  , gowning practices, contamination control, sample handling, chain of custody, laboratory testing support, laboratory equipment use, Good Documentation Practices, and ALCOA+ data integrity expectations.
• Ability to support training related to applicable 21 CFR expectations, including cGMP
  , electronic records/electronic signatures, drug storage/distribution, documentation controls, laboratory controls, and regulated quality system processes.
• Ability to interpret and incorporate applicable USP chapters, client requirements, SOPs, specifications, test methods, sampling procedures, and quality requirements into training materials and competency assessments.
• Strong technical writing capability for SOPs, work instructions, job aids, checklists, training guides, qualification records, assessments, audit tools, and resource materials.
• Advanced Excel,…