Training Coordinator - Tier 4, Life Science Division

Job Description

Job Description

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.