Learning & Development Specialist (Pharmaceutical / cGMP)

Premier Staffing Solution, LLC; Greenfield (IN); On-site; USD 85,000 - 125,000; Full time

Benefits offered by this job

Health insurance

Career growth

Job summary

Premier Staffing Solution, LLC seeks an advanced Training Coordinator IV to own and elevate the training framework for our regulated pharmaceutical warehouse, clean room, and sampling operations in Greenfield, IN. This role translates 21 CFR, cGMP/GDP, and USP standards into practical, competency-based qualification programs and auditable records.

In close partnership with Quality, Operations, Laboratory SMEs, EHS, site leadership, and client stakeholders, you will develop training matrices,

Qualifications

• GxP & Pharma expertise in cGMP/GDP, 21 CFR, and data integrity.
• Ability to build practical On-the-Job (OJT) checklists, training guides, and robust competency assessments for lab or controlled environments.
• Strong Excel and LMS reporting skills to track KPIs and present data to leadership.

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: Develop rigorous training for aseptic behavior, gowning qualification, contamination control, and sample handling.
• Audit & Inspection Readiness: Ensure training assignments, qualification checklists, and competency records are accurate and retrievable for FDA, client, and internal audits.
• Gap Analysis & Remediation: Conduct training needs assessments for new client requirements or SOP revisions; create remediation plans tied to deviations and CAPAs.
• LMS/QMS Administration: Support course configuration, curricula logic, and compliance dashboards within site systems.
• Mentorship & Functional Guidance: Provide training direction and train-the-trainer support across shifts.

Skills

GxP & Pharma Expertise

Technical Training

Analytical Thinking

Collaborative Communicator

Education

Bachelor's degree in Life Sciences, Chemistry, Microbiology, Quality, Education, or related field

Job description

Location - Greenfield, IN (no relocation available and no VISA candidates or C2C/C2H or W2)

The Training Coordinator IV is an advanced-level, site-focused training role responsible for establishing, maintaining, and continuously improving the training program for a regulated warehouse operation that stores pharmaceutical products and performs sampling and testing activities in a clean room and/or laboratory environment This role is responsible for all applicable Training Coordinator III responsibilities, with increased emphasis on pharmaceutical cGMP/GDP expectations, laboratory controls, clean room behavior, contamination control, sample handling, data integrity, and competency-based qualification.

The Training Coordinator IV partners closely with Quality, Operations, Laboratory/Sampling personnel, EHS, site leadership, Corporate Quality, and client stakeholders to translate 21 CFR, USP, client, SOP, and site-specific requirements into effective training matrices, curricula, qualification programs, job aids, assessments, and training effectiveness measures. This role supports audit and regulatory inspection readiness by ensuring training assignments, records, and competency evidence are accurate, current, controlled, and readily retrievable.

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.