Detailed oriented Quality Assurance Professional with 15+ years of diversified and challenging positions in a research setting. Reputation as someone who could be counted on to 'get the job done' ensuring business objectives were met. Experience includes implementing and maintaining compliance for a variety of regulations and providing QA oversight in an Biotechnology Contract Research Laboratory. Recognized for excellent interpersonal skills and the ability to be comfortable and capable interfacing with both internal clients and external auditors along with technical experience and a Masters of Science.
2006 to 2010
Provided leadership for teams of up to 11 members running the day to day exposure operations of a Contract Research Organization supporting US and international clients on an ongoing basis.
• Reduced Quality Assurance audit findings by 35% within 9 months of transferring to the Engineering group by conducting training, revamping procedures and conducting internal assessments.
• Worked with study staff ensuring Exposure Operations events occurred as scheduled and within budget.
• Wrote calibration and maintenance procedures for measuring and test equipment.
• Liaised and assisted Health and Safety Officer with tasks meeting regulatory and health and safety requirements for the facility and hazardous materials and waste.
• Worked with Engineering Task Leaders ensuring study tasks were completed on time and within budget.
• Validated Excel spreadsheet in accordance to Standard Operating Procedures (SOPs).
• Validated exposure systems and computer systems for compliance with regulations (Good Laboratory Practices (GLP) and 21 CFR part 11).
• Met study deadlines through effective supervision of Engineering Technicians on a day to day basis who were performing Exposure tasks.
• Conducted training of staff to project requirements, procedures and for process improvements.
• Reviewed data for compliance with study protocol, SOP and GLP regulations.
• Wrote and revised SOP for studies, equipment and facility operations.
• Reviewed study reports against study data for accuracy.
Quality Assurance Officer
1997 to 2006
Became an informal liaison between the Quality Assurance Unit and the Technical groups resulting in increased communication and a better understanding of the purpose of the regulations and clients requirements.
• Personally migrated Master Schedule from paper records to MS Excel database.
• Implemented a supplier evaluation program.
• Assisted in external surveillances and audits by government and client auditors.
• Conducted facility (analytical, engineering, and animal labs) and project specific surveillances. Reported findings and recommended corrective action to management and followed up to document corrective action taken.
• Evaluated the compliance of studies to FDA, EPA and OECD GLP regulations, study protocols and SOPs by performing surveillances and tracking corrective action.
• Evaluated computer, equipment and system validations for compliance with facility procedures and regulations (GLP and 21 CFR part 11).
• Conducted data (paper and electronic) and report audits.
• Assisted project mangers to establish procedures to assure GLP compliance.
• Reviewed sampling and analysis procedures and activities.
• Generated and delivered training for staff and management on regulatory, procedural and Health and Safety requirements.
• Maintained computerized files of the Quality Assurance Unit including Master Schedule, inspection scheduling, planning and reporting.
• Wrote and maintained SOPs for the operations of the Quality Assurance Unit.
• Reviewed proposals, SOPs and study protocols for completeness, accuracy, and compliance with current regulations and statements of work.
• Prepared cost estimates for proposals.
1993 to 1995
• Wrote project-specific Quality Assurance plans to client requirements (NQA-1, 10 CFR 830).
• Trained as NQA-1 Lead Auditor.
• Participated in audits of subcontractors' facilities.
• Performed internal audits and surveillances onsite and at remote field project locations.
• Provided primary support to the Waste Management / RCRA facility to insure compliance to EPA, DOT, and PNNL requirements.
• Conducted assessments of packaging and shipping hazardous and radioactive wastes to RCRA and DOT regulations.
• Inspected onsite and offsite treatment, storage, disposal, and transportation of hazardous and radioactive wastes.
• Prepared and reviewed field and laboratory procedures.
• Conducted assessments of ground water, surface water and soil sampling activities to various procedures including EPA protocols, and assessments of packaging and shipping hazardous and radioactive wastes to RCRA and DOT regulations
• Conducted data audits of reports.
• Assisted in the establishment a QAU for the conduct of EPA GLP studies, this included writing SOPs, maintaining files, conducting inspections and data audits.
• Interfaced with line management, project management, scientists, technicians, and external clients.
MS in Environmental Science
BS in Geology
Areas of expertise include
• Good Laboratory Practices (GLP)
• Quality Assurance
• Supplier and Internal Audits / Surveillances
• Instrument Calibration
• Computer and Spreadsheet Validation
• Instrument Qualification / Acceptance / Validation
• Client / Federal Audit Hosting
• Microsoft Office
• Corrective Action Tracking