Experience

DPT Laboratories

• United States
• Pharmaceutical Manufacturing
• 300 - 400 Employee

• • Aug 2012 - Present

  QC - Raw Materials - Test Standard Revisions and Change Controls Assess all USP/NF, EP, FCC and BP publications and their additional supplements, as well as all USP errata, revision bulletins and IRAs for any potential updates that would require test standard revisions. Revise test standards per compenidial updates, customer specifications, or customer request and route the appropriate changes through a change control. Work collectively with customers and other DPT departments to ensure that change controls are closed in an appropriate time frame. Develop and maintain relationships with customers for current and future projects. Review released test specifications and Quality Agreements to evaluate if a material qualifies for the reduced testing program.  Verify inventory adjustments, expiration dates and retest dates of released materials. Draft customer and in house methods into current DPT formatting and route the appropriate changes through a change control. Review historical data, perform gap analyses, and present any findings or potential problems to management with a solution to prevent future issues. Perform Effectiveness Checks to ensure that CAPAs are complete.  Perform master batch calculations. Fulfill quality requests from QA (i.e. obtaining BSE/TSE statements, allergen statements, residual solvents statements, etc. from vendors). Perform technical review of proposed and investigational testing. Help with laboratory training when needed. Show less

• • May 2010 - Aug 2012

  QC - Raw Materials - Laboratory Performed chemical and physical testing on various raw materials and reference standards using compendial, non-compendial, and proposed methods. Ensured testing was conducted in a timely fashion and within an approved, established framework (SOPs, cGMPs, customers’ requirements, etc) to maintain customer supportability. Participated in OOS (Out of Specification) investigational testing. Performed technical review of completed tests, including all documentation. Sampled raw materials for testing. Developed methods for the Raman spectrometer. Maintained laboratory reagent inventory, including ordering of reagents and maintaining inventory spreadsheet. Trained new hires in all their functions and duties. Facilitated team performance center meetings. Coordinated and maintained testing schedule for team. Maintained records/logs for team KPIs. Composed and delivered presentations to management regarding team KPIs.  Ensured that the laboratory was compliant with applicable quality and regulatory requirements. Show less