Quality Control Laboratory Manager Bioanalytical Science Resume Example

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Jessica Claire
Montgomery Street, San Francisco, CA 94105
Home: (555) 432-1000 - Cell: - - -
Executive Profile

Performance driven pharmaceutical/biotechnology professional with twenty-four years industry experience including six years in Quality Assurance, seven years in Quality Control, and eleven years in Operations/Manufacturing. A strategic leader with seventeen years of managerial and supervisory experience.

Core Strengths
  • High performing team development
  • Quality systems oversight
  • Risk based decision making
  • Metric development & monitoring
  • US & Global inspection experience
  • Non-conformance and CAPA management
  • Leading continuous improvements
  • Problem solving skills
  • Interpersonal relationships
  • Project management
  • Current Good Manufacturing Practices expertise
Professional Experience
02/2007 to Current
Quality Control Laboratory Manager - BioAnalytical Science Bbcn Bank Niles, IL,
  • Manage testing activities for bioassay, EIA, and PCR analysis.
  • Responsible for ensuring transfer activities, method remediation, and validations are completed per timelines.
  • Key member in the merging of Analytical Science activities into Quality Control Laboratory for BioAnalytical Sciences.
  • Perform method trending, invalid assay analysis, out of specification investigations, non-conformance investigations and CAPA implementations. Complete change control activities and assessments.
  • Developed and implemented metrics to monitor activities within the laboratory
  • Lead group in continuous improvements and lean six-sigma activities.
  • Participate in inspections from FDA and global regulatory agencies as well as internal audits.
07/2005 to 03/2010
Volunteer - Business Manager Amgen Inc. Oklahoma City, OK,
  • Performed bookkeeping, budgeting, bill paying, and insurance billing.
  • Prepared taxes yearly.
  • Set-up business accounts with vendors to receive discounts on necessary products.
  • Reviewed office documents for compliance with HIPPA and insurance requirements.
  • Advised on budget to hire personnel and move to a better office.
07/2006 to 01/2007
GMP Documentation Reviewer Albertsons Company Inc. Fairbanks, AK,
  • Performed review of NDA submission documentation, including CMC data, method validations, validations, clinical trial reports, and various sections of the submissions document.
07/2005 to 01/2007
Serology Testing Supervisor Labcorp Cypress, TX,
  • Supervised off-shift laboratory tissue testing to ensure regulatory compliance and timely release of results.
06/2004 to 06/2005
Interim Director of Quality Jbs Usa Sauk Rapids, MN,
  • Quality oversight of facility activities.
  • Management of quality systems including non-conformance, Biological Product Deviations, change control, material review board, computer system validations and internal auditing.
  • Host FDA inspections and corporate audits. Complete responses to findings and implement corrective actions.
04/2003 to 06/2004
Quality Assurance Officer - North Central Area American Red Cross City, STATE,
  • Lead North Central Area regions' implementation of a new non-conformance system as the result of a Consent Decree requirement.
  • Formally trained in problem solving tools and root cause analysis as part of non-conformance system implementation.
  • Reviewed specific corporate SOPs for compliance with Consent Decree requirements.
  • Supported quality oversight activities for blood processing regions throughout the North Central Area.
  • Traveled to support region's inspections and audits.
  • Performed system audits across regions.
01/2002 to 04/2003
Quality Assurance Officer American Red Cross - San Diego Testing Laboratory City, STATE,
  • Quality oversight at two testing facilities, one in San Diego and one in San Bernadino as well as the consolidation of testing to San Diego.
  • Oversight of the laboratory consolidation included monitoring the implementation of a new deionized water system.
  • Reviewed extensive amounts of validation plans and documentation for instrumentation and methods as part of laboratory consolidation.
  • Hosted and participated in FDA inspections.
  • Performed system audits.
  • Approved and reviewed non-conformances, change controls, and SOPs.
09/2000 to 01/2002
Sr. Associate QA American Red Cross - Detroit Testing Laboratory City, STATE,
  • Performed weekly audits of testing documentation.
  • Approved non-conformances and corrective action plans.
  • Reviewed change controls.
  • Lead facility system based audits.
  • Participated in FDA and EMA inspections.
09/1999 to 09/2000
Interim Manger /Supervisor Nucleic Acid Testing American Red Cross - Detroit Testing Laboratory City, STATE,
  • Designed and set-up a testing laboratory for a new testing methodology.
  • Completed and oversaw the completion of all validations associated with the implementation of the new testing methodology.
  • Created the laboratory workflow.
  • Interviewed and hired the technicians to staff the laboratory.
  • Supervised testing and personnel on the second shift.
02/1998 to 09/1999
Manufacturing Quality Assurance Supervisor Ferndale Laboratories City, STATE,
  • Supervised the Manufacturing Quality Assurance group which oversaw the manufacturing and packaging of dermatological pharmaceuticals such as creams, lotions, ointments and gels as well as medical devices.
  • Reviewed and approved manufacturing and packaging batch records.
  • Performed lot disposition and release.
  • Monitor staff performing finished product inspection.
  • Verify packaging documentation and package inserts.
  • Participated on non-conformance, change control, validation, and audit teams.
11/1994 to 09/1999
Lead Lab Technologist EIA and Automation Laboratories American Red Cross - Detroit Testing Laboratory City, STATE,
  • Participated in the consolidation of testing from many regions across the country to the new Detroit Testing Laboratory. This involved moving instrumentation to the new building and performing many validations of instruments. Designed a process flow to manage an increase in testing from 250 samples to 2400 samples per shift.
  • Oversight of laboratory testing and sample processing in the Enzyme Immunoassay (EIA) laboratory where blood samples were tested for infectious diseases on the third shift.
  • Oversight of the laboratory testing and sample processing in the Automation laboratory where high throughput testing of blood typing, antibody detection and liver enzyme analysis were completed on the third shift.
  • Created staff scheduling to maximize throughput while still allowing for staff work-life balance on the third shift.
  • Performed problem solving of issues that arose during the shift.
  • Wrote and revised SOPs and testing documents.
02/1992 to 11/1994
Lab Technologist American Red Cross - Southeastern Michigan Region City, STATE,
  • Performed testing of blood samples for infectious diseases via EIA methods.
  • Typed blood samples for ABO Rh blood type.
  • Analyzed samples for the presence of antibodies.
  • Wrote and revised SOPs and testing documents.
06/1990 to 02/1992
Laboratory Technician American Red Cross - Fort Wayne Region City, STATE,
  • Performed routine testing of blood products for infectious diseases via EIA methods.
  • Performed instrument and method validations.
  • Wrote SOPs and various testing documents.
Expected in
Bachelor of Science:
University Saint Francis - Fort Wayne, Indiana

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Resume Strength

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Resume Overview

School Attended
  • University Saint Francis
Job Titles Held:
  • Quality Control Laboratory Manager - BioAnalytical Science
  • Volunteer - Business Manager
  • GMP Documentation Reviewer
  • Serology Testing Supervisor
  • Interim Director of Quality
  • Quality Assurance Officer - North Central Area
  • Quality Assurance Officer
  • Sr. Associate QA
  • Interim Manger /Supervisor Nucleic Acid Testing
  • Manufacturing Quality Assurance Supervisor
  • Lead Lab Technologist EIA and Automation Laboratories
  • Lab Technologist
  • Laboratory Technician
  • Bachelor of Science