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Jessica
Claire
resumesample@example.com
(555) 432-1000,
Montgomery Street, San Francisco, CA 94105
:
Professional Summary

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 University Upper Montclair, New Jersey Expected 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
  • All responsibilities of QA Coordinator
Ohl - Quality Assurance Coordinator
Lansing, MI, 03/2004 - 2007
  • 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
  • Provide site wide training on SOPs
  • Conduct product quality investigations
  • Perform internal and external GMP audits
Exova - Microbiologist
Longmont, CO, 10/2001 - 03/2004
  • Ensure proper microbiological methods and limits are placed on raw material and finished product specifications
  • Perform risk assessments on finished products based on input raw materials and manufacturing processes and formulation characteristics
  • Coordinate outsourcing of microbiological testing
  • Execute an environmental monitoring program of the GMP pilot plant
  • Execute a monitoring program of the USP purified water system
  • Write SOPs, microbiology test methods and microbiology validation reports
Exova - Microbiologist
Melbourne, FL, 06/2001 - 10/2001
  • Operate Vidas, Vitek and BAX automated systems
  • 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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Resume Overview

School Attended

  • Montclair State University

Job Titles Held:

  • Quality Assurance Specialist
  • Quality Assurance Coordinator
  • Microbiologist
  • Microbiologist
  • Microbiologist

Degrees

  • Bachelor of Science

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