Experience

United States Drug Testing Laboratories (USDTL)

• United States
• Hospitals and Health Care
• 1 - 100 Employee

• LIMS and Salesforce Manager

  • Mar 2021 - Present

• Applications Administrator

  • Jul 2015 - Mar 2021

  • LIMS Administrator for Chemware Horizon v11.2. • Salesforce Administrator. • Perform backup duties for the Network Administrator.

• LIMS Administrator

  • Jul 2013 - Jul 2015

  • LIMS Administrator for Chemware Horizon v10.2.



Baxter International Inc.

• United States
• Medical Equipment Manufacturing
• 700 & Above Employee

• Research Associate II

  • Feb 2006 - Jul 2013

  • Conduct laboratory evaluations for Stability Operations and Product Development utilizing a wide variety of instrumental and wet chemical methodology. Evaluate data and perform investigations of unexpected results. • Study director for validation protocols. Monitor conduct. Prepare and review technical reports to insure completeness and scientific validity. Actively research additional technical information using external and internal sources. Communicate data and related information appropriately. • Site administrator for SQL*LIMS v5.1. Key team member for implementation of version 5.1. Updated SOP’s. Performed user acceptance testing. Performed training and provide support for 35 users. Design and author Crystal Reports. • Computer System Owner of GPC data acquisition computer system and Tiamo Metrohm Software. Completed OQ/PQ of Cirrus software v2.1. Show less



Apotex Inc.

• Canada
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Analytical Chemist III

  • Aug 2004 - Aug 2005

  •Responsible for commercial stability program. Managed stability studies and testing schedule. Performed OQ/PQ of stability chambers. Negotiated and managed purchase and construction of walk-in stability rooms. Wrote and trained on new SOP's. •Matrix Plus LIMS Project Lead. Implemented, validated and supported LIMS software in accordance with 21 CFR Part 11. Designed reports including C of A's with Crystal Reports. Authored User's Manual. Migrated legacy data to the new LIMS. •Performed release and stability testing of commercial product including Assay by HPLC, ID by UV-Vis, Dillon force, Hunter Color and pH. Show less



Wockhardt USA

• United States
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Stability Coordinator

  • Nov 2003 - Aug 2004

  •Wrote Annual Product Reviews for 70 commercial products. Interacted with QA Lab, Compliance and Regulatory to prepare Annual Reports. Evaluated and reviewed stability and batch records to provide recommendations for specifications and product improvement. •Provided support for daily operation of stability chambers. •Stability WinLIMS Administrator. Created stability studies in Stability LIMS. •Wrote Annual Product Reviews for 70 commercial products. Interacted with QA Lab, Compliance and Regulatory to prepare Annual Reports. Evaluated and reviewed stability and batch records to provide recommendations for specifications and product improvement. •Provided support for daily operation of stability chambers. •Stability WinLIMS Administrator. Created stability studies in Stability LIMS.



Pfizer

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Associate Scientist II, R&D Stability

  • Nov 1999 - Nov 2003

  •Represented stability group in various project teams for new product identities. Provided support and expertise to the team. Interacted with regional, corporate and international team members to ensure all stability needs are fulfilled on time. Responsible for pre-clinical stability to NDA for multiple product candidates. Product line includes parenteral and solid formulation. •Performed stability data evaluation and report writing for regulatory agencies (US, EU and Canada). Wrote expiry reports for new drug substance and products. •SQL*Stability LIMS Administrator. Implemented and trained SQL*Stability and SQL*LIMS 4.0 for Skokie site. Designed and performed OQ of LIMS reports. Provided Stability LIMS support for 130 users. Member of LIMS core working team. •Stability Lab coordinator. Performed daily operations of stability lab. Performed audits for Stability Lab of Contract Research Organizations. Show less