Quality Specialist II

Neogen; Lexington (KY); On-site; USD 52,000 - 68,000; Full time

Job summary

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).

Qualifications

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

Responsibilities

• 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.

Education

High school diploma or GED

Job description

Come Be Part of a Mission that Matters! Quality Systems Specialist We are seeking an individual to support Quality Systems management by executing various activities such as 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.

Schedule: Monday - Friday, 2nd shift (2:30 PM - 11:00 PM)

Responsibilities:

• 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.

Qualifications:

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

WHO IS NEOGEN:

From farm to fork, we offer solutions to enhance the quality, quantity and safety of the global food supply. Our animal safety solutions are used on farms, veterinary practices and manufacturers around the world to provide the best animal care possible. Whether food or pharmaceuticals, Neogens provides a one-stop shop for the health and safety to our animals and our customers operations. Neogens culture combines stability with a deep belief in providing professional and personal growth. Our Pillars of Trust the principles that guide our everyday decision-making, include Openness, Honesty, Credibility, Respect, and Service. Its our belief in these characteristics that provides a consistent, happy and healthy work environment for our employees. At Neogens, we are extremely proud of our record of sustained growth, as well as our development and acquisition of advanced technology since our founding in 1982. Neogens has thrived - and will continue to thrive - because our employees thrive here.