LEAD QUALITY SPECIALIST

Contract Pharmaceuticals Limited - Niagara, Buffalo, NY February 2010 - present (plant closing 2011)

Manager of Quality Assurance (titled Lead Quality Specialist) of a Lean Focus Factory which produces pharmaceutical products in tubes with 4 direct reports. Responsible for approval and release of product through Quality Control data and Manufacturing batch production records. Responsible for approval of investigations, deviation, CAPA, Change Control, and audit responses in addition to validation protocols, stability studies, annual product review, cleaning validations and SOPs. Reviews product Certificates of Conformance / Certificates of Analysis for product release. Conducts customer Quality calls and Project calls as well as collaboration with customers on changes which impact their product. Participates on teams for new products and product development to assure they are validated and complaint with cGMPs. Aiding in technology and validation transfer activities due to plant closure in 2011.

QC Microbiology supervisor

Emergent BioSolutions, Lansing, 2007- January 2010

Supervisor of 24-7 Environmental Monitoring and Quality Control Microbiology department (9 employees). Responsible for approval of QC Microbiology data and release of production lots based on review of QC data. SOP, deviation, CAPA, Change Control, and audit response review and approval. Knowledge of current CFR, cGMP, and EU pharmaceutical requirements. Conduct audits of Quality Control laboratories on a weekly basis. Collaborate with manufacturing, validation, and Critical Utilities and provide input on risk assessments for capital projects. Coordination of major projects and change controls including document approval, testing, validation and regulatory documentation. Supply Tracking and Trending reports to management review and track Key Process Indicators for Quality Control testing to improve test result turn around time. Proficient in the use of Microsoft Office, SAP and LIMS Thermo SampleManager.

QC Microbiology Associate Scientist

Emergent BioSolutions, Lansing, MI 2004 - 2007

Daily tasks included QC Microbiology testing (Environmental Monitoring, Biological Indicator testing, Visual Inspection, LAL, Total Microbial Count testing of water systems (Milli-flex system)), deviation writing, and collaboration, change control collaboration and closure, SOP revisions, CAPA writing and execution, corrective action determination and execution. Other duties include helping to organize sampling and testing schedules for shutdown and startup of critical utility systems, organizing data for release of systems, tracking and trending of environmental monitoring samples, and frequent collaboration with ofther departments on a variety of projects when QC input is required. Miscellaneous tasks include sample ordering in LIMS, data approval, knowledge of cGMP, Certificate of Conformance review and preparation, requesting testing based on tracking and trending of environmental samples, and use of all program in Microsoft Office Suite and SAP.

Stability assistant scientist

Celltech Pharmaceuticals, Rochester, NY 2003 - 2004

Daily duties included product testing FDA approved products for a variety of different products while abiding by cGMP. Tests conducted included pH, dissolutions, moisture, friability, active ingredient assays and handling of DEA controlled substances. Worked on validation of new product and reformulation of current products including notebook studies and conducting validation according to protocols. Instrumentation use included HPLC, and UV/Vis.

Wet chemistry analyst

Severn Trent Laboratories, Amherst, NY 2001-2003

Daily duties included analysis of environmental water and soil samples for nitrates, nitrites, pH, alkalinity, chlorine, ammonia, conductivity, cyanide, reactivity, total kjeldahl nitrogen, phenol, chlorine, sulfate, silica, hardness, biological oxygen demand, chemical oxygen demand, total organic halides and total organic carbon by EPA approved methods. Tests carried out using multiple types of instrumentation including flow injection, colorimetric spectrometry, TOC analyzer and amperometric titration testing.

INTERNSHIP

Erie County Central Police Services Forensic Laboratory, Buffalo, NY 2002

Focus of internship was ballistic and trace evidence processing. Final paper included analysis of automotive paint samples using Fourier Transform Infrared spectroscopy. Observation of evidence presentation in court room and general overview of analysis of DNA using Genetic Analyzer, PCR, and STR, fingerprint, toxicology, serology, and arson evidence.

Education

Spring Arbor University - Lansing, MI — Masters of Arts in Organizational Management, 2007

State University of New York at Buffalo - Amherst, NY - Masters classes in Chemistry - 2002 - 2003

State University College at Buffalo - Buffalo, NY - Bachelor of Science in Forensic Chemistry and a minor in Biology, 2002

Professional development

Risk Based Decision Making Seminar by David Beggs Associates - Philadelphia, PA - March 2009

American chemical society member - 2002 - present

Parenteral drug association member - 2007-PRESENT