Batch Record Reviewer (3rd Shift)

About the role

Summary: Responsibilities include review of line documentation related to contract packaging. Will follow up on customer inquiries as they relate to same documentation and compliance issue. Complete final review and release for product distribution. The impact of review process directly impacts company compliance to regulatory requirements and customer satisfaction.

Responsibilities

• Responsible for review of documentation related to primary, secondary, and clinical packaging after completion of reconciliation.
• Responsible for critical review and logging of all above documentation for errors, omissions, over-writes and compliance to cGMP