Quality Documentation Specialist II - Oakwood Labs
Solon, OH 44139
About the Job
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.