Quality Documentation Specialist II - Oakwood Labs

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.