Quality Systems Specialist II: ISO & cGMP Compliance

Neogen Corporation; Lexington (KY); On-site; USD 55,000 - 75,000; Full time

Job summary

Neogen Corporation seeks a Quality Systems Specialist to support the Quality Management System, including corrective actions, batch record reviews, documentation maintenance, supplier quality, and audit program administration. This role ensures compliance with ISO standards, cGMPs, and customer expectations while providing training and support for quality policies and procedures.

Monday–Friday, 2:30 PM–11:00 PM, 2nd shift.

Qualifications

• 1-3 years of related experience or equivalent combination of education and experience.
• Knowledge of ISO standards and cGMPs.
• Ability to support training and guidance on quality policies and procedures.

Responsibilities

• Maintain and monitor the quality management system programs.
• Identify areas requiring corrective/preventive actions and implement solutions.
• Provide training and support on quality policies and procedures.
• Assist in ISO and internal audits as needed.
• Assist in writing SOPs, product standards, and batch records.
• Compile data to support quality trending programs.
• Enforce compliance with product batch records and standards.
• Support investigations on minor nonconformances.

Skills

Quality systems

Auditing

Training

Corrective actions

Education

High School Diploma or GED

Job description

Neogen Corporation seeks a Quality Systems Specialist to support the Quality Management System, including corrective actions, batch record reviews, documentation maintenance, supplier quality, and audit program administration. This role ensures compliance with ISO standards, cGMPs, and customer expectations while providing training and support for quality policies and procedures.

Monday–Friday, 2:30 PM–11:00 PM, 2nd shift.