Reliable, dedicated professional with extensive experience in a wide range of areas within the pharmaceutical environment, including formulation, analytical lab testing, batch record review, documentation, clinical packaging, data review, auditing, CAPA, instrument calibration and training programs. Personable team player, conscientious, reliable, and flexible. Detail oriented, enjoy working with data and numbers and finding & fixing flaws in systems. • ASQ Certified Quality Auditor (Dec 2013) • Excellent oral and written communication skills • Good analytical skills • Over 20 years’ experience in FDA regulated environment, GXP, quality management • Previous experience in batch formulation, lab techniques (wet chemistry, HPLC, GC, UV, IR, AA), Documentation, batch record & label review and approval

Highlights:

• GMP
• SOP Revision
• Training
• Documentation
• Calibration
• Investigation