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Joy
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Project manager/QA-QC
Job Type: Full-Time

Education

From 0 to 2008
MBA - University of Delaware - Lerner College of Business and Economics
From 0 to 2004
BSc. - University of Delaware, USA
No added languages

Experience

Validation Engineer / Project Manager
BE&K Engineering, a KBR company, USA
August 2007 - March 2009 (1 year 8 months)

Validation

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 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 finished on time and within the new budget. Relationship with client was rectified and another project was offered 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 budget

Laboratory Manager
Microbial Identification, Inc. USA
May 2005 - June 2007 (2 years 2 months)

o Managed DNA sequencing laboratory

o Responsible for 3 laboratory technicians

o Ensured laboratory was GLP compliant

  • Equipment validation & Preparation of Standard Operating Procedures

o Liaison between external customers and senior management in providing customer quotes and expediting services

o Offered service to ensure customers understood microbial ID reports

o Investigated and troubleshoot problems and ensured DNA sequencing process was completed within budget and ahead of schedule