Experience

Osmotica Pharmaceutical Corp.

• United States
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• QA Manager

  • Jul 2011 - Present



Shionogi Inc. (U.S.)

• United States
• Pharmaceutical Manufacturing
• 300 - 400 Employee

• Quality Assurance Consultant

  • Feb 2011 - Jun 2011

  Investigated discrepancies from contractors related to product manufacture and/or packaging. Wrote discrepancy reports and CAPAs. Followed up with contractors to ensure closure of discrepancies. Investigated discrepancies from contractors related to product manufacture and/or packaging. Wrote discrepancy reports and CAPAs. Followed up with contractors to ensure closure of discrepancies.



Abbott Products Inc. (formerly Solvay Pharmaceuticals, Inc.)

• Manager, QA CPD & Distribution Support

  • Sep 2006 - Feb 2011

  Managed QA group responsible for compliance of analytical data and marketed product distribution. Reviewed protocols, reports, method validations, and Standard Operating Procedures for content. Performed internal audits and monitor corrective actions. Supported equipment qualification activities. Supported manufacturing activities. Released clinical materials. Served as QA delegate for various projects. Managed QA group responsible for compliance of analytical data and marketed product distribution. Reviewed protocols, reports, method validations, and Standard Operating Procedures for content. Performed internal audits and monitor corrective actions. Supported equipment qualification activities. Supported manufacturing activities. Released clinical materials. Served as QA delegate for various projects.



Solvay Pharmaceuticals

• QA Documentation Auditor

  • Jan 2002 - Sep 2006



Solvay Pharmaceuticals

• Technical Writer

  • Sep 2000 - Apr 2001

  Wrote, edited, and organized analytical reports, protocols, out-of-specification investigations, and Standard Operating Procedures. Wrote, edited, and organized analytical reports, protocols, out-of-specification investigations, and Standard Operating Procedures.



Oread, Inc.

• Supervisor, Pharmacetical Analysis

  • Jul 1998 - Aug 2000

  Work for a CRO to provided analytical support by evaluating and validating analytical methods. Organized and oversaw projects and analysts from beginning to end. Reviewed analytical results and prepared written reports. Interacted directly with clients as needed. Work for a CRO to provided analytical support by evaluating and validating analytical methods. Organized and oversaw projects and analysts from beginning to end. Reviewed analytical results and prepared written reports. Interacted directly with clients as needed.



Mikart, LLC

• Pharmaceutical Manufacturing
• 100 - 200 Employee

• Quality Control Manager

  • Mar 1991 - Jul 1998

  Managed a group of analysts in a production setting. Set goals that were reviewed regularly as a group. Reviewed method validation reports and wrote Standard Operating Procedures. Participated in and responded to FDA and customer audits. Managed a group of analysts in a production setting. Set goals that were reviewed regularly as a group. Reviewed method validation reports and wrote Standard Operating Procedures. Participated in and responded to FDA and customer audits.