Document Reviewer / Analyst

Position Summary

The Document Review is responsible for reviewing specifications, procedures, protocols and batch records for Good Manufacturing Procedures (GMPs) compliance to support the release and stability of finished products.

Performs a variety of administrative tasks to support QC, Processing, and Lab. Completes special assignments and projects as required. In addition, all employees are expected to work on any assignment-determined necessary by the team or management to ensure team success. All Administrative support participates in a team environment where shared responsibilities, problem solving, achieving team goals, and continuous improvements of the overall process are basic expectations.

Responsibilities/Duties:

• Responsible for batch and thermal process record review of records, QC testing, in process data records and HACCP support documents in accordance with company policy and food safety regulations. Issue Finished Product releases subsequent to internal and State Regulatory review.
• Reviews validation protocols for Good Manufacturing Practices (GMP) compliance.
• Perform reviews of batch production and control records for product and initiate investigation for any unexplained discrepancy found during review, reports findings to FSQA Manager.
• File and maintain batch production and control records.
• Coordinate and track completion of action items generated due to deviations and change control requests.
• Follow up investigation close out and corrective actions
• Assist in developing local area network program to capture and analyze process and production data as required.
• Administrative support as needed
• Expected to function as an engaged employee and contribute to the site’s continuous improvement efforts.