Quality Systems Specialist: Batch Records & Compliance

Neogen; Lexington (KY); Presencial; USD 52 000 - 68 000; Tempo integral

Resumo da oferta

Neogen in Lexington, KY seeks a Quality Systems Specialist to support ISO and cGMP compliance by performing corrective actions, batch record reviews, documentation maintenance, supplier quality activities, and audit program administration.

This role involves training and supporting quality policies, writing SOPs, managing change controls, and providing real-time QA support to operations while compiling data for quality trending. Schedule is Monday–Friday, 2nd shift (2:30 PM–11:00 PM).

Qualificações

• High school diploma or GED required.
• 1-3 years of related experience or an equivalent combination of education and experience.

Responsabilidades

• Utilize and monitor manual and software programs within the quality management system.
• Identify areas requiring additional quality support or corrective/preventative actions.
• Provide training and support on quality systems, policies, and procedures.
• Assist in maintaining and communicating company quality policies and procedures.
• Issue and audit batch records and manufacturing procedures.
• Assist in ISO and internal audits as needed.
• Support the writing of SOPs, product standards, and batch records.
• Maintain documentation related to change control, operations, batch records, training, validations, calibrations, and qualifications.
• Troubleshoot and provide real-time quality support to operations.
• Compile data to support quality trending programs.
• Enforce compliance with product batch records and standards.
• Assist QC personnel in releasing incoming raw and packaging materials.
• Support investigations on minor nonconformances.

Formação académica

High school diploma or GED

Descrição da oferta de emprego

Neogen in Lexington, KY seeks a Quality Systems Specialist to support ISO and cGMP compliance by performing corrective actions, batch record reviews, documentation maintenance, supplier quality activities, and audit program administration.

This role involves training and supporting quality policies, writing SOPs, managing change controls, and providing real-time QA support to operations while compiling data for quality trending. Schedule is Monday–Friday, 2nd shift (2:30 PM–11:00 PM).