Montgomery Street, San Francisco, CA94105609 Johnson Ave., 49204, Tulsa, OK
Home: (555) 432-1000
Cell:
resumesample@example.com
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
Education
Bachelor of Science: Biology, Expected in May 1997 Neumann College - Aston, PA GPA:
Graduated Magna Cum Laude
Experience
Microbiology Analytical Laboratory Supervisor, 2007 to 03/2013 West-Ward Pharmaceuticals/Baxter Healthcare – City, 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.
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