Batch Record Coordinator

The QA Batch Record Reviewer ensures compliance with written policies and procedures and that final documentation is complete as required for batch release. This individual will work in a office setting with a focus on detail-oriented compliant review of records. This individual must be able to manage a work load of varying priorities while adhering to strict deadlines.

• Perform first quality review of executed batch records.
• Disposition Hold notices as applicable.

• Review and certify component release documentation.
• Review released raw material documentation for production use.
• Review of specific in-process, and finished product test data.
• Document retrieval from local files and archives, as required for submissions and customer requests.
• Assist in process audits as needed.
• Coordinate receipt of executed batch paperwork from production.
• Routine interaction with other departments for purposes of collecting batch record information or working to resolve documentation issues.