Barbara Relation Email & Phone Number

Reviews in process and finished product documentation to ensure compliance with cGMP, SOP and FDA regulations for release of product. Provides recommendations and takes appropriate action to ensure compliance. Identifies and resolves discrepencies, incidents, errors and deficiencies. Actively manages Work In Process (WIP) priorities to ensure timely completion of batch record audit and release of product. Supports management in investigations, recommends corrective action for resolution of issues to remain consistent with cGMPs, SOP's and company policy. Applies methods and procedures to arrive at sound conclusions, compiles, enters and proofreads Annual Product Review (APR) data. Regular updating and maintain of product master files, and Issuance of proper documentation to support production. Provides high quality customer service at all times. Trains and instructs new employees. Backup auditor for review and release of API's, components, labels and supply items in SAP.

Reviewed and reconciled packaging batch records, and ordered supplies for the department. Maintained and distributed end of the month downtime reports for upper management. Maintained and distributed packaging reports. Edited and corrected documentation errors per Product Release Auditor's requirements. Copied and filed line clearances, hold notices and training records. Distributed department mail. Maintained weekly department charts for WIP area, dry area, cooler and controlled temperature rooms. Distributed department logbooks on a yearly basis and distributed productivity reports on a daily basis.

Filled radioactive I-125 seed orders for distribution. Date entry and calibrated caintecs for use. Assayed lower range seeds for correct activity. Kept track of orders shipped weekly and clerical errors for upper management. Calibrated seeds for specific orders.