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Training Coordinator IV - Pharma Compliance & GxP

Job in South Bend, St. Joseph County, Indiana, 46601, USA
Listing for: Langham Logistics Inc.
Full Time position
Listed on 2026-11-01
Job specializations:
  • Quality Assurance - QA/QC
    Regulatory Compliance Specialist, QA Specialist - Analyst/Manager
Salary/Wage Range or Industry Benchmark: 90000 - 120000 USD Yearly USD 90000.00 120000.00 YEAR
Job Description & How to Apply Below

Are you an expert in pharmaceutical compliance who thrives at the intersection of quality assurance, workforce readiness, and technical education? Langham Logistics is seeking an advanced-level Training Coordinator IV to own, elevate, and continuously improve the training framework for our regulated pharmaceutical warehouse, clean room, and sampling operations.

In this site-focused leadership role, you won't just track compliance—you will translate complex 21 CFR, cGMP/GDP, and USP standards into practical, robust, competency-based qualification programs. If you are a collaborative problem-solver ready to ensure audit readiness and build a culture of data integrity and operational excellence, we want you on our team.

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.

Experience & Education Preferred
  • Education:

    Bachelor's degree in Life Sciences, Chemistry, Microbiology, Quality, Education, or a related field strongly preferred.

  • 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. You will 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.

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