Senior GxP Training Coordinator for Clean Room & Lab

Langham Logistics Inc.

Greenfield (IN)

On-site

USD 60,000 - 75,000

Full time

20 hours ago
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Job summary

Langham Logistics Inc. in Greenfield, IN, is seeking a Training Coordinator IV to own and elevate the training framework for our regulated pharmaceutical warehouse operations.

You will translate 21 CFR, cGMP/GDP, and USP standards into practical, competency-based programs, ensure audit readiness, and mentor site trainers across shifts. This role blends office work with field support on the warehouse floor.

Qualifications

  • 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.

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 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 audits.
  • Gap Analysis & Remediation: Conduct training needs assessments for new client requirements or SOP revisions; develop targeted training remediation plans tied to deviations and 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.]
  • CoT_job_summary_short":"COMPANY NAME: Langham Logistics Inc.\nKEY POINTS: Training leadership, pharma compliance, audit readiness"
  • job_summary_short':'<p>Langham Logistics Inc. in Greenfield, IN, is seeking a Training Coordinator IV to own and elevate the training framework for our regulated pharmaceutical warehouse operations.</p><p>You will translate 21 CFR, cGMP/GDP, and USP standards into practical, competency-based programs, ensure audit readiness, and mentor site trainers across shifts. This role blends office work with field support on the warehouse floor.</p>'
  • contract_type

Skills

Excel
LMS reporting
Data integrity
GxP knowledge
Collaborative communicator

Education

Bachelor's degree in Life Sciences

Job description

Langham Logistics Inc. in Greenfield, IN, is seeking a Training Coordinator IV to own and elevate the training framework for our regulated pharmaceutical warehouse operations.

You will translate 21 CFR, cGMP/GDP, and USP standards into practical, competency-based programs, ensure audit readiness, and mentor site trainers across shifts. This role blends office work with field support on the warehouse floor.

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