Microbiology QC QA Process Engineer - Biotech Resume Search
Microbiology QC QA  Process Engineer - Biotech Resume Search
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Microbiology/QC/QA /Process Engineer Resume


Desired Industry: Biotech SpiderID: 49998
Desired Job Location: Lexington, Kentucky Date Posted: 4/15/2011
Type of Position: Full-Time Permanent Availability Date: 04/18/11
Desired Wage: negotiable
U.S. Work Authorization: Yes
Job Level: Management (Manager, Director) Willing to Travel: Yes, 25-50%
Highest Degree Attained: Masters Willing to Relocate: Yes


Objective:
Currently seeking a full-time position


Experience:
Management of 3-Microbiologist crew.
Worked closely with other groups including formulation development, engineering and manufacturing.
Followed change control procedure for manufacturing activities and documentation. Maintained lab instruments, reference standards, lab chemicals, inventory and documentation as per SOPs.Participation in engineering studies related to terminal sterilization products and different compounding stages (dispersion and homogenization).
As part of the writing of final report for the engineering studies, the review and interpretation of data such as viscosity, particle size and assay testing at different parts of the engineering study process.
Reviewed laboratory notebooks and test results as per SOP requirement.
Management of 6-Microbiologist crew.
Directs the daily workflow for the Microbiology department
Oversees all aspects of performance management including regular evaluations for staff
Provide hands-on-training and guidance to Associates
The microbiology laboratory services both as a Manufacturing support laboratory and a QC Laboratory therefore oversees scheduling of staff and ensuring that procedures and methods are performed according to the proper Standard Operating Procedures (SOP)
Supervising routine and special microbiology testing activities which include (i.e. Sterility Assurance, Sterilization Validation Studies, Pharmacopeia Sterility Tests, Growth Promotion Studies, Environmental Monitoring, Microbial Identification, Bioburden Test and Antimicrobial Tests)
Developing, characterizing, and validating microbiological and chemical analytical test methods.
Periodic technical transfer of validated methods to client laboratories.
Participation in development or revision of Quality System and Laboratory Control System SOPs and policies
Participation in periodic quality reviews of policies, procedures, data, and records
Supporting operations and manufacturing by sample collection, analysis, and reporting of results for product, raw materials, and utility systems
Schedules lab testing activities, assures the accuracy and timeliness of technical reports, reviews and approves testing results and signs test reports.
Reviews all positive results and unusual or unexpected testing results and supervises CAPA and Investigations as appropriate
Assists in the hiring and selection process


Education:
Bachelor of Science in Chemical Engineering, Carabobo University, Venezuela July 2001
Courses taken included:
Chemical Process Synthesis Polymer Engineering
Process Control Principles Thermodynamics I & II
Kinetic and Chemical Reactor Design Process Design I
Environmental Preservation Transport Phenomena I, II and III
Resistance of Materials Physical Chemistry I and II
Minors: Petrochemicals, Food Engineering, and Environmental Engineering

English as a Second Language (completed), University of Kentucky.USA. Nov, 2002
Master in Sciences in Biosystems and Agricultural Engineering Program from the University of Kentucky.USA


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