Back to search
Are you an expert in pharmaceutical compliance who thrives at the intersection of quality assurance, workforce readiness, and technical education? We are 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.
Learn more about this Employer on their Career Site
