Quality Documentation Specialist II

Oakwood Labs
Solon, OH, US
Full-time

Job Description

Job Description

We are growing and adding to our quality team!

Essential job functions include :

  • Generate, issue, reconcile, and archive batch records and protocols
  • Author batch records and protocols including to support new product demonstrations
  • Perform batch record review and collaborate with various department to resolve discrepancies and ensure Good Documentation Practices are followed,
  • Administer area SOP and change control related to documentation.
  • Manage Oakwood’s GMP document retention program
  • Compile and maintain key performance indicators and facilitate continuous improvement

Attributes required include :

  • Bachelor’s degree in science or related discipline, or commensurate experience in GMP Regulated industry
  • Three years’ experience in an FDA regulated or ISO (high tech) manufacturing environment preferably in a Quality or documentation role, and
  • Strong computer skills, to include Microsoft Word and Excel.
  • 3 days ago
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