Quality Assurance Specialist Iii

NITTO DENKO Corporation

Cincinnati, Ohio, US
On-site
Cgmp practices documentation and auditing
Develop and revise qa procedures
Review quality records and batch records
NITTO DENKO Corporation is seeking a Quality Assurance Specialist III for its Cincinnati, Ohio facility. The role involves ensuring compliance with cGMP practices, conducting audits, and providing training, requiring a strong background in quality assurance and regulatory standards

Job Summary

  • The position is responsible for documenting and auditing cGMP practices for the site.
  • Key Responsibilities include reviewing quality records/batch records and co-hosting quality audits to ensure cGMP compliance.
  • The job requires a BS/BA in science or equivalent work experience with 3-5 years experience in either Production or Quality Assurance.

Matching Summary

Match Score: 85

NITTO DENKO Corporation is seeking a Quality Assurance Specialist III for its Cincinnati, Ohio facility. The role involves ensuring compliance with cGMP practices, conducting audits, and providing training, requiring a strong background in quality assurance and regulatory standards.

Skills & Requirements

Must-have

  • cGMP practices documentation and auditing
  • Develop and revise QA procedures
  • Review quality records and batch records
  • Co-host vendor and internal quality audits
  • Provide cGMP training to site staff
  • Review and approve deviations, OOT, and OOS
  • Act as QA representative on project teams

Nice-to-have

  • Strong communication link between departments
  • Maintain current knowledge of regulatory changes

Key Requirements

  • BS/BA in science or equivalent work experience
  • 3-5 years experience in Production or Quality Assurance
  • Expert advice and sound decision-making on cGMP
  • Strong knowledge of cGMP regulation
  • Experience in Quality Systems
  • Strong attention to detail and self-checking skills

Work Rights

Not specified

Tailored Resume

Cover Letter