The primary purpose of the QA Specialist position is to perform internal audits of Manufacturing/CMC procedures; track and maintain SOPs, Work Instructions, Lab Notebooks, and Manufacturing numbers; perform Batch Record preparation, issuance, and verification; perform official batch release. The QA Specialist fills in for the Senior Manager QA/QC upon the manager’s absence. Other tasks are detailed below:
Maintain equipment logs and files.
Trace manufacturing numbers.
Internal audits of manufacturing process.
Write audit reports.
Maintain SDS, CoA, Chemical Lists.
Keep track of new employee CV/Job Description
Write new SOPs and BRs.
Keep track of lab notebooks.
Provide support for the Investigation and Recall of non-conforming materials.
Perform Batch Record preparation, issuance, and verification.
Issuance of Controlled Labels and Forms.
Fill in for Sr. Manager QA/QC in absence.
Other activities as assigned.