Training Coordinator - Tier 4, Life Science Division
Langham Logistics · Greenfield, IN · 2 wk ago
On-siteHuman ResourcesFull-time
Key Responsibilities
- Program Ownership: Architect and maintain risk-based, role-specific training matrices for warehouse operations, pharmaceutical storage, clean room entry, and laboratory sampling/testing.
- Specialized Clean Room & Lab Support: Partner with Quality and Laboratory Subject Matter Experts (SMEs) to develop rigorous training for aseptic behavior, gowning qualification, contamination control, and sample handling.
- Audit & Inspection Readiness: Ensure all training assignments, qualification checklists, and competency records are highly accurate, data-integrity compliant (ALCOA+), and immediately retrievable for FDA, client, and internal audits.
- Gap Analysis & Remediation: Conduct training needs assessments for new client requirements or SOP revisions; develop targeted training remediation plans tied to deviations and corrective actions (CAPAs).
- LMS/QMS Administration: Support course configuration, curricula logic, and compliance dashboard reporting within the site's learning/quality management systems.
- Mentorship & Functional Guidance: Provide technical training direction, coaching, and train-the-trainer support to site trainers, supervisors, and designated area experts across shifts.
What We Are Looking For
- GxP & Pharma Expertise: Deep working knowledge of pharmaceutical cGMP/GDP expectations, 21 CFR requirements, and data integrity principles.
- Technical Training Background: Proven ability to build practical On-the-Job (OJT) checklists, technical training guides, and robust competency assessments for complex laboratory or controlled environments.
- Analytical Thinker: Advanced skills in Excel and LMS reporting to track key performance metrics, drive down repeat training-related errors, and present clear data to leadership.
- Collaborative Communicator: A natural mentor capable of influencing without direct authority and seamlessly aligning floor operations, quality teams, and client stakeholders.
Education & Experience
- PREFERRED EDUCATION: Bachelor's degree in Life Sciences, Chemistry, Microbiology, Quality, Education, or a related field.
- EXPERIENCE: 5+ years of progressive experience in training/L&D, pharmaceutical quality, laboratory operations, or a highly regulated GxP environment.
- CERTIFICATIONS: Clean room gowning, train-the-trainer, ASQ, GMP, or related technical certifications are highly valued.
Work Environment & Physical Demands
- This role integrates office work with active field support. Regularly walk warehouse floors, enter access-controlled or temperature-controlled environments, and closely observe clean room/laboratory practices.
- Full compliance with site PPE, hygiene, and gowning requirements is mandatory.