Job Order: 4607
Staff Representative: Tim Jadwin
Position: Stability Coordinator
Location: Illinois
Company Summary:
A leading supplier of specialty and generic liquid pharmaceutical products.
Description:
Responsibilities:
Coordinate and perform all activities related to the Stability, Annual Product Review and Product Retention Evaluation programs in compliance with Company SOPs and cGMP Regulations.
Typical Duties:
- Stability
- Prepare stability sampling and testing schedules. This will include all products to be placed into the annual controlled room temperature system, and the pulling of periodic test station samples within that program.
- Maintain data tracking systems and perform trend analysis of Stability test results. Initiate alert reports to associated areas when trends are indicative of shelf life excursions, or test results are atypical.
- Assist in maintaining the Stability chambers for chambers for adherence to established environmental requirements and auditing of stability logbooks.
- Annual Product Review
- Compile required sections of data for inclusion in the final APR report.
- Prepare a brief summary report of data reviewed in each section of the Annual Product Review (APR).
- Product Retention Evaluation
- Prepare the schedules for the evaluation of selected retention samples and the pulling of periodic test station samples within the product retention evaluation system.
- Distribute samples at required intervals to areas performing evaluations. Assist in stability room sample logbook audits on a bi-annual basis.
- General
- Initiate Incident or Discrepancy Reports for any applicable nonconformances.
- Perform other duties as assigned by Stability Department management.
- BS/BA degree in a scientific discipline
- A minimum of 1-2 years experience in a pharmaceutical analytical laboratory
- Experience in the performance and/or review of stability testing
- Knowledge of analytical testing equipment and procedures
