Quality control/project manager
BE&K Engineering and Construction-BioPharm group, Newark, DE USA
February 2007 - December 2009 (2 years 11 months)
Quality Control Management
o Responsible for field projects in Equipment, Process, and System validation in support of the FDA regulated industries
o Specialties in Validation, Commissioning, QA/QC, ISO 9001:2000 certification and 21 CFR Part 11
o Area of activity include cGMP, GLP and GCP compliant efforts
o Project management
• Recovered project that had passed its proposed completion date and was $30,000 over budget under the previous management. Project was completed on time and within the new budget. Relationship with client was rectified and another project was awarded within the same facility.
o Preparation and Execution of Validation Protocol & Engineering design package
o Ensure the consistency of manufacturing operation and reproducibility of process
o Ensure the existence of all the necessary quality assurance systems within org.
o Provided business development effort
o Ensure client support is within budgetLaboratory Management
o Managed DNA sequencing laboratory
o Ensured laboratory was GLP compliant
• Equipment validation & Preparation of Standard Operating Procedures
o Liaise with customers and senior management in providing customer quotes and expediting services
o Managed procurement functions for laboratory supplies and equipment servicing
o Investigated and troubleshoot problems and ensured DNA sequencing process was completed within budget and ahead of schedule
➢ Marketing Research Consultancy
o Newport Redevelopment Project for Harvey-Hanna and Associates, Inc.
• Assisted in the master planning of a large-scale commercial land redevelopment project in the town of Newport, Delaware
o Marketing Development Research for Aetna Fire Hall, Newark, Delaware
• Developed marketing strategies to increase organization’s sales and profit
o Tradeshow exhibitions for BE&K’s Engineering and Validation services
o Company Analysis for Tiffany & Co.
• Market Analysis and Strategy Formulation to increase competitiveness
➢ Research & Development
o Performed experimental procedures in identifying various protein functions in Chlorobium tepidum
o Co-authored a 2005 publication in Journal of Bacteriology: Analysis of genes encoding potential sulfur oxidation activities in Chlorobium tepidum by in vitro transposition mutagenesis