Pharma L&D Lead: cGMP Training & Audit Readiness

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

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,