The Role Responsible for:
- The review and approval of processing files prior to product processing. The review ensures accurate product codes for numbers, case count, and cycle specifications.
- The review of processing files after product processing, and prior to product release, in order to ensure processing parameters have been met.
- Assists with the review of operating logs (spectrophotometer, gamma dose computational software log, pre-conditioning, aeration and maintenance) to ensure timely and accurate record keeping processes.
- Assists with the review and maintenance of calibration records to ensure calibration is performed properly and in a timely manner.
- Assists with writing deviations and documenting Customer concerns based on established Customer specifications and QS/RC policies and procedures.
- With direction from the QS/RC Manager or Analyst, assists with corrective actions as required by process deviations, procedure deviations, complaints, regulatory audits, Customer audits, and internal audits.