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SHABANA
US-Texas-Austin
Microbiology Professional
Seeking a research position with an innovative corporation
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iac Liquid Particle
Counter, Scan RDI, Eppendorf electronic(digital) pipettor
- Qualified to enter sterile areas, Researched Isolator Technology, Autoclaves
- Proficient in Windows XP, (Word, Excel, PowerPoint) and Core Templates, CORAL, LIMS,
(QMS)Trackwise
- Coordinate Outsourcing to Contract Lab
- Completed ETO sterilization training
- Completed Aseptic Processing 2-day Course
- Completed 6-day Aseptic Training in Manufacturing
EXPERIENCE
QA Microbiology Professional (October 2006-Present)
Allergan, Inc.
Waco, TX
Responsibilities:
Supervisory role in Support Aseptic Processing at the Waco manufacturing facility; Provide oversight of media fill program and aseptic gown qualification program for Unit Dose, Sterile Fill, Ointment, Gel, and Steroid products; Prepare validation protocols and final reports for media fills; Write media fill investigations; Schedule media fill dates; Provide training to Production personnel; Monitor filling process; Oversee Day-7 and Day-14 media inspections; Contribute to SOP revisions; Work closely with Planners, Validation, QA, Microbiology Professionals, Fill Supervisors, Engineers, and Batch Review Dept. to meet Customer Service timelines; Oversee Microbiology lab water testing of site, microbial limits testing, disinfectant studies, BI testing, bioburden testing; Manage customer complaints sent from Corporate; Prepare and present trend reports; Order media supplies; Supervise and mentor hourly personnel; Participant in investigative teams; Support internal and external audits.
Associtate Research Scientist (April 2003-Oct. 2006)
Bristol-Myers Squibb Co.
New Brunswick, NJ
Responsibilities:
Write Microbiological Qualification Protocols for R&D and BMS Worldwide Technology Transfers, Write Laboratory qualification reports, Review SOPs against current compendia, Manage Long-term Stability Studies, Research new equipment and host vendor presentations, Validate new equipment (IQ/OQ/PQ), Write IOPs for new equipment, Conduct dept. meetings and training, Conduct lab safety audits and perform monthly checks of safety equipment, contact facilities for equipment repair and follow-up, Supervise all water testing for 2 sites and report results/OOS, Validate new water system, Validate R2A Media, Develop an environmental monitoring program, Perform Laboratory Investigations, Perform daily review of notebooks and autoclave charts, Perform weekly review of Incubator and Refrigerator temperature charts, Compile laboratory inventory lists and order media supplies, Provide input on the design of a future Micro. Lab, Provide training to Analysts, Samplers, and Facilities and Manufacturing personnel, Approve employee timecards and OT.
Assistant Scientist (1999 - 2003)
Ortho Biotech (Johnson&Johnson), Raritan, NJ
Major Responsibilities: Environmental monitoring of manufacturing,purification and filling areas, sampling and testing of water (including LAL), microbial limits testing, bioburden testing, water activity, preservative efficacy testing, BI certification, growth promotion, identification of microorganisms, monitoring laboratory equipment, freezing and shipping samples, initiating investigations, trending data, and performing lab safety audits.
Micro Lab Technician (1998-1999)
Nice-Pak Products, Inc, Orangeburg, NY
Major Responsibilities: Team leader in charge of environmental monitoring, microbial limits testing, sampling and testing water, sterility and bioburden testing, calibration of incubators using RL-100 temperature recorders, growth promotion, media preparation, maintenance of stock cultures, writing investigations, and autoclaving.
Quality Control Technician (1997 - 1998)
Cintas Cleanroom Resources, Newburgh, NY
Major Responsibilities: Washer validation, water testing, environmental monitoring of cleanroom, performing particle counts and resistivity tests on garments, penicillin testing, monitoring HEPA filter velocities and cleanroom temperatures, inspecting incoming components, bioburden, writing and revising SOPs, trending, autoclaving, and sanitization of cleanroom.
REFERENCES
Available upon request
EDUCATION
B.S., Biology/Pre-med Major (1998)
Mount Saint Mary College, Newburgh, NY
Fairleigh Dickinson University, Madison, NJ
Presidential Scholarship
University Honors Program
ACTIVITIES
PDA Conferences
Habitat for Humanity
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