Jessica Claire
  • Montgomery Street, San Francisco, CA 94105 609 Johnson Ave., 49204, Tulsa, OK
  • Home: (555) 432-1000
  • Cell:
Professional Overview

OBJECTIVE: To obtain a senior or management position supporting Quality Assurance/Quality Control in a laboratory setting. SUMMARY OF QUALIFICATIONS: Over fourteen (14) years of experience in a cGMP pharmaceutical Microbiology laboratory setting

Core Qualifications
  • Knowledgeable and skilled in laboratory techniques
  • Experienced in scientific writing
  • Experienced in process and product development
  • Experienced in Microbiology test method validation
  • Highly proficient in bioburden, bacterial endotoxin and microbiological assays
  • Ability to lead and supervise effectively
  • Highly motivated individual with excellent personal and communication skills
  • Excellent leadership qualities
  • Excellent attention to detail
  • Knowledgeable of USP, EU, FDA, DEA, GMP, GLP and CFR guidelines
  • Team player and can work well individually
Bachelor of Science: Biology, Expected in May 1997
Neumann College - Aston, PA

Graduated Magna Cum Laude

Microbiology Analytical Laboratory Supervisor, 2007 to 03/2013
West-Ward Pharmaceuticals/Baxter HealthcareCity, STATE,
  • Responsible for supervising a group of ten employees (Microbiologists and Analysts)
  • Responsible for supervising the analytical laboratory where routine tests are performed to meet product release (bioburden and bacterial endotoxin testing of incoming raw materials and components, bulks, finished products, and Water for Injection)
  • Responsible for writing, reviewing and approving Standard Operating Procedures (SOPs), Laboratory Investigation Reports (LIRs), and Manufacturing Investigation Reports (MIRs)
  • Responsible for reviewing test method procedures, change controls, protocols and laboratory notebooks
  • Responsible for ensuring laboratory is in compliance with GLP requirements
  • Responsible for training all new employees
  • Responsible for ordering and maintaining supplies for the analytical laboratory including adhering to a yearly budget
  • Responsible for ensuring quality metrics are met
  • Responsible for reviewing monthly and quarterly trending reports
  • Responsible for staffing personnel to meet production schedules
  • Responsible for reviewing API and finished product specification
  • Release raw materials, components and finished products for Production
  • Member of numerous teams for new product launches as well as problem solving teams
  • Analyze and interpret microbiological testing data and recommend preventative and corrective actions regarding microbiological issues
Microbiologist I, II, IV and V, 05/1998 to 2007
Baxter Healthcare / Wyeth-Ayerst(ESI Lederle)City, STATE,
  • Routine sample, bioburden and LAL test WFI
  • Perform LAL testing and bioburden testing on bulks, finished products, raw materials, and components.
  • Develop test methods for bulk bioburden validation and LAL validation
  • Perform microbiological assay testing on bulks, finished products, and raw materials
  • Perform identification of organisms
  • Perform maintenance and calibration on laboratory equipment
  • Perform IQ, OQ, and PQ on new laboratory equipment Write and execute protocols for special projects
  • Write Laboratory Investigation Reports and Manufacturing Investigation Reports on OOS and atypical findings
  • Trained in LIMS System
  • Train employees in new procedures Trained in sterility method, bioburden method and LAL method validation.

Avid runner and basektball player

Volunteer coach at grade school for 20 years

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Resume Overview

School Attended

  • Neumann College

Job Titles Held:

  • Microbiology Analytical Laboratory Supervisor
  • Microbiologist I, II, IV and V


  • Bachelor of Science

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