Quality Assurance Control

Experienced Pharmaceutical scientist with expertise in the GMP compliant handling and submission of samples submitted for Quality Control testing according to FDA, EU and JP testing requirements. Performs trending, tracking of testing records and reports in Compliance with cGMP’s. Able to work independently or as part of a multidisciplinary team.

Professional Experience

Summary

Medarex Inc., Bloomsbury, NJ 2002- October 2010

Senior Sample Submission Controller

● Responsible for insuring that samples requiring testing are received and stored properly.

● Starts chain of custody in LIMS and shipping samples to Bloomsbury as well as contract laboratories for testing. Also contacts Bloomsbury personnel about any issues affecting testing. That may interfere with scheduled testing.

● Performs daily checks of the refrigerator/freezer and assists in troubleshooting any equipment failures to prevent impact on submitted samples.

● Responsible for distributing QCID#s and Batch Records to QC, Manufacturing, Analytical and Formulation Development departments.

● The Sample Controller is responsible for organizing all reference material used in the Quality Control department.

● Organizes and compiles QC test results for release, stability studies, and reference standards, in-process testing, and process validation. Provides other departments with the status of sample testing.

● Received an award for devising and initiating a method for tracking the transfer of test data folders to QA.

● Creates spreadsheets and reports for Technical Operations meetings.

● Schedules Stability Sample test and specifications in LIMS.

● Aliquots Final Container samples for testing and places in the appropriate storage condition.

● Trends QC Immunology Assay test results for stability.

● Tracts and trends Invalid Assays, OSS and Atypical test results. Providing charts and tables to determine the reason for assay problems.

● Enters static data as a LIMS Administrator.

● Utilize LIMS to track samples and test results submitted for testing in QC.

● Transferred product release, stability and in-process data to Quality Assurance.

● Distributes QC Reference Standards on request to analyst.

● Provides information to Quality Assurance to facilitate the location of Batch Records.

Bristol-Myers Squibb, New Brunswick, NJ 1995-2001

Stability Program Associate – Quality Control

Reviewed production schedule and scheduled sampling of products for stability testing. Insured that samples were maintained and/or delivered to the laboratory in order to meet government testing requirements. Coordinated the receipt of sample for testing from offsite facilities located internationally. Ensured the accuracy of the data file for all stability samples. Maintained Mask Header/Activity/Activity files according to SOP CSS31. Initiated Annual Product Data reports for all products that were subsequently sent to the FDA. Provided stability information for the Complaint and Statistics Department upon request.

● Created and designed a database using Microsoft Access to provide stability information to internal sources.

● Reduced the amount of sample needed for testing resulting in savings of up to 33%.

● Successfully coordinated sample requirements and information with testing facilities in Puerto Rico and Canada. Received an award for solving stability sampling problems in Humacao, Puerto Rico.

● Packaged, distributed and maintained reference standards for stability testing.

● Investigated samples that did not meet specifications.

● Determine the root cause for non-compliance.

● Provided product characteristics to testing laboratories.

Technical Expertise

● Gas Chromatography

● Paper, thin layer and liquid chromatography

● pH Measurements

● Spectrophotometry

● Dissolution testing using an auto-analyzer

● HPLC

● Viscosity

● Visual Inspection

Education/Certifications

● Instrumental Analysis – St. Joseph College, Hartford, CT

● Advanced Inorganic Chemistry – Lehigh University, Bethlehem, PA

● B.S. Chemistry – Moravian College, Bethlehem, PA

Training/Computer Skills

● Conducted New Employee Sample Submission Training

● Attended semi-annual cGMP training sessions

● Administrator of Medarex Laboratory Information/Quality Management Systems (LIMS)

Computer Skills

LIMS/QMS, E-Documentation, Microsoft Excel, Microsoft Access, Microsoft Outlook, Word

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