A competent, self-motivating professional that is results oriented with over ten years of Quality Assurance experience and six years of Microbiology experience. Knowledgeable and competent in drug cGMP and maintaining an effective Quality Management System, with all actions and decisions governed by ensuring patient safety and product quality and efficacy.
Core Qualifications
QMS review and maintenance
Batch record review and batch release
Quality documents review and approvals (change control, deviation, OOS investigations)
Use of Root Cause Analysis tools for product quality investigations
CAPA development and implementation
Training in GxP processes
Education
Montclair State UniversityUpper Montclair, New JerseyExpected in – –Bachelor of Science:Molecular Biology - GPA:Dean's List
Graduated Cum Laude
NJPQCA certified
Experience
Allegiant Air - Quality Assurance Specialist Alcoa, TN, 2007 - Current
Investigated using RCA tools the potential source of extrinsic contamination in tablet batches and implemented effective preventative measures
Successfully led the integration of the Stiefel quality assurance group into the GSK Consumer Healthcare R&D QMS, which resulted in the use of a new GMP pilot plant ahead of schedule
Conducted a GEMBA exercise and presented an FMEA to upper management to identify and communicate the product quality risks of manufacturing a nasal spray in a toothpaste manufacturing facility intended for terminal sterilization
Planned and led the cleaning validation activities for the taste sample development laboratory and the glassware washer to ensure compliance to the GSK QMS
Provided training on cleaning validation/verification, analytical OOS laboratory investigations and vendor approval and management to GxP personnel in house and at CMOs
Provide new product development teams with clear and timely written and verbal guidance on quality requirements throughout the product development lifecycle
Approve drug, medical device and food batches for human use studies
Perform line clearances in the pilot plant
Review and approve master manufacturing records and executed batch records
Release of raw materials
Review and approve equipment IQ/OQ/PQ protocols and reports
Support cleaning validation/verification and represent QA on the cleaning review team
Write, review and approve SOPs, specifications and microbiology test methods
Review and approve microbiology validation reports
Analyze raw materials and finished products for Salmonella sp. using BAM and ELISA methods
Determine microbial quality or raw materials and finished products
Perform environmental monitoring of the production plant
Prepare media and reagents and maintain laboratory quality control programs
Exova - Microbiologist Milpitas, CA, 09/1997 - 06/2001
Devised, performed and evaluated a protocol for heterotrophic plate counting of deionized water
Investigated variability associated with the AOAC Phenol Coefficient Method (Abstract submitted to the American Association of Microbiologists)
Write SOPs and GLP testing reports
Perform GLP and experimental testing using the following test methods: AOAC Use Dilution and Germicidal Spray Methods, European Suspension Test (EN1276), Therapeutic Goods Act for Australia, Antimicrobial Effectiveness Testing, Microbiological Challenge Test of Food Products, Operation of Biomek 2000 Laboratory Automated Workstation
Provide verbal/written summaries of test results to formulating chemists
Perform cell passaging for virology studies and maintain stock bacterial cultures
Auditing of log books and experimental reports
Maintain laboratory quality control programs
Coordinate outsourcing of microbiological testing
Skills
Excellent verbal and written skills
Pays attention to detail and acts with a sense of urgency
Team player that can work across boundaries to find solutions
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