QA/QC Specialist

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.

Training.

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.

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