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. Applicant Tracking Software by

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Training Coordinator - Tier 4, Life Science Division