Barbara Relation Email & Phone Number

Melrose Park

Processes Change Notices (CNs) using Documentum Computer SoftwareProcesses Document Change Requests (DCRs)Reviews SOPs (Standard Operating Procedures)for site documentation activitiesEstablishes and maintains up to date central files (archives) on subjects including but not limited to:Standard Operating ProceduresPoliciesMaster Component SpecificationsProduct SpecificationsDocument Change Requests

* Creates Structured Product Labeling (SPL) format using specialized software for FDA submissions * Proof reading of labeling artwork; review draft and final labeling for compliance with USP and FDA requirements * Responsible for update/revisions of product labeling utilizing innovator or leading competitor labeling of FDA deficiency letters * Provides labeling (draft or final printed labeling) in response to deficiency letters within a timely manner based on corporate priorities; responsible for accurate interpretation of deficiency letters, providing accurate, approvable labeling for FDA submissions * Reviews proposed USP labeling revisions to ensure timely implementation for APP products * Provides labeling support for all active application annual reporting regulatory requirements

Review in process and finished product documentation to ensure compliance with cGMP, SOP and FDA regulations for release of product. * Comprehensive review of product manufacturing, packaging and test documentation * Identify and resolves discrepancies, incidents, errors and deficiencies * Provides recommendations and takes appropriate action to ensure compliance * Actively manage, Work In Process (WIP) priorities to ensure timely completion of batch record audit and release of product * Support management in manufacturing investigations, recommend corrective action for resolution

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.

Radioactive seeds/devicesFilled radioactive I-125 seed orders for distribution. Data entry and calibrated capintecs 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.

Radioactive seeds/devicesReviewed production batch records for accuracy and completeness and ordered production and office supplies. Maintained attendance records, sick time and vacation logs. Maintained time sheets/payroll for the department; typed scrap reports and graphs and filed documents for the department.