Quality Specialist II

Neogen CorporationLexington, KY
Onsite

About The Position

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.

Requirements

  • High school diploma or GED required; additional education is desirable.
  • 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.
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