Quality position - Biotech Resume Search
Quality position - Biotech Resume Search
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Quality position Resume


Desired Industry: Biotech SpiderID: 51216
Desired Job Location: Lexington, Kentucky Date Posted: 5/25/2011
Type of Position: Full-Time Permanent Availability Date: immediately
Desired Wage: 70,000
U.S. Work Authorization: Yes
Job Level: Management (Manager, Director) Willing to Travel: Yes, Less Than 25%
Highest Degree Attained: Masters Willing to Relocate: Yes


Objective:
Highly knowledgeable and results-driven Microbiology Analyst and Lab Supervisor with extensive experience in drug product development and current good manufacturing practices (cGMP). Valued expertise in process validation including installation qualification (IQ), operation qualification (OQ), performance qualification (PQ), and IOPQ. Demonstrate high level of initiative and problem-solving skills in complex scientific environments. Design, execute, and supervise progressive studies and analyses that deliver practical solutions to desired client requirements.


Experience:
Hired, trained, and manage teams of up to 6 including Microbiology Analysts and Intern responsible for facility and water system (WFI, Clean Steam, purified, RO/DI, and potable) environmental monitoring, raw material and finished product testing, and report generation. Supervise routine and special microbiology testing within ISO class 5, 7, 8, and unclassified (controlled) environments including sterility assurance, sterilization validation studies, pharmacopeia sterility tests, growth promotion studies, microbial documentation, bioburden and antimicrobial testing, particle matter testing for injectable products, and Container Closure Integrity (dye immersion) testing. Direct environmental investigations and implement corrective/preventative actions.
Ensure strict adherence to FDA, International Society of Professional Engineers (ISPE), Parenteral Drug Association (PDA), and United States Pharmacopeia (USP) regulations and guidelines. Develop, characterize, and validate microbiological and chemical analytical test methods. Oversee development/revision of quality system and laboratory control system standard operating procedures (SOP). Direct creation and execution of method validation protocols and micro test methods for material releasing testing. Assist executive management team including CEO in developing and presenting budget proposals.


Education:
Master of Science in Biosystems and Agricultural Engineering, University of Kentucky, Lexington, KY 2010
Thesis: Evaluation of Chlorella Vulgaris growth in the presence and absence of a possible flue gas component
Received “Outstanding Graduate Student” honor and member of Alpha Epsilon honor society
Bachelor of Science in Chemical Engineering, University of Carabobo, Valencia, Venezuela 2001
Thesis: Evaluation of the wastewater treatment plant for the reutilization of its effluence for the irrigation facility of the green areas of the company


Affiliations:
Member of Alpha Epsilon honor society


Skills:
Laboratory Management • Protocol Development • Aseptic Process & Sterilization Validation • Staff Training
Quality Evaluation • Regulatory Compliance • Total Organic Carbon (TOC) Cleaning Verification
Process Engineering • Budget Management • Results Reporting • Formulation Development


Reference:
Available upon request.


Candidate Contact Information:
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