Experience

Societal™ CDMO (formerly Recro)
• Metrologist II

  • Aug 2021 - Present

Mikart, Inc.
• United States
• Pharmaceutical Manufacturing
• 1 - 100 Employee
• QC Analyst II

  • Aug 2013 - Mar 2020


Nice Pak Products

• Australia
• Manufacturing
• 1 - 100 Employee

• Packaging R&D

  • Jan 2012 - Oct 2012

  Managed test requests to ensure on-time completion and quality of reporting by reviewing and approving test reports. Performed stability testing by analyzing product moisture loss over time and developed prototype models/samples for clients as dictated by Marketing. Working knowledge of metrology, in particular for weight, dimensional, tensile, compression, and drop testing. Supported the Product Development group in developing formulations for OTC products to meet target specifications. Performed HPLC, GC, and titration analysis (sample/standard prep, setup/run instruments, perform calculations, record and document results). Show less



Pfizer (formerly Wyeth)

• Scientist I

  • Jun 2005 - Feb 2011

  Provided full range of metrology management and support for instruments across R&D labs, such as HPLC, dissolution bath, UV-Vis, IR, GC, and other specialty instruments to ensure systems and equipment are consistently maintained and operated. Wrote, executed, and reviewed over 500 instrument qualification protocols (IQ/OQ/PQ) to certify data integrity. Authored and reviewed SOPs and methods. Provided key support for FDA, PAI audits and other regulatory inspections. Managed compliance related processes including instrument and software validation using GMP, 21 CFR Part 11 and GAMP standards. Conducted Laboratory and Process Discrepancy investigation reports and developed impact assessment, corrective and preventative actions (CAPA). Show less