Quality Assurance Professional with 20 years of diversified and challenging positions in research and manufacturing settings. Expert in GLP (FDA, OECD, EPA) regulations, experience in the GMPs and training in ISO 9001, & GCPs. Experience implementing and maintaining compliance for a variety of regulations, internal and external auditing, providing QA oversight in manufacturing laboratories, analytical laboratories and toxicology CROs. Recognized for excellent interpersonal skills, establish good working relationships with those I support and the ability to be comfortable and capable interfacing with both internal clients and external auditors along with technical experience and a Master’s of Science.
Quality Assurance Auditor / Archivist
December 2011 to Present
The facility moved and lost their prior QA staff prior to my arrival, so I was expected to hit the ground running. I now lead a QA Unit of 2 ½ staff as the department continues to grow.
• Train QA staff and allocate duties and responsibilities.
• Conduct contract lab qualification audits and work with them to insure compliance, open communication and continued working relationships.
• Conduct audits/inspections of study events, data, reports, procedures and facilities.
• Provide regulatory assessment prior to study conduct to prepare for study submission to the US EPA.
• Establish SOPs and policies to insure compliance.
• Advise management and staff of compliance, regulatory and professional practices.
• Supervise QA and Archive staff to insure functions are performed and customer needs are met.
• Conduct training sessions on GLP trends and practices for technical staff and management.
• Host Environmental Protection Agency investigators during compliance audits.
• Control and administer GLP archives.
Quality Assurance Specialist
August 2011 to December 2011
A not-for-profit Contract Manufacturing Organization which researches and develops novel, advanced diagnostics, adjuvants, vaccines, and other therapeutic products for the diagnosis, prevention and treatment of diseases of poverty under the FDA Good Manufacturing Practices Regulations (cGMPs).
QA Auditor in a small GMP CMO.
• Facility inspections
• Vendor/subcontractor audits/qualifications
• Conduct batch record review
• Procedure writing and review
• Data and report audits
• Equipment validations
• Corrective and Preventive Action implementation and tracking.
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
RQAP-GLP (Registered Quality Assurance Professional, Good Laboratory Practices)
October 2011 to December 2017
Professional accreditation granted by the Society of Quality Assurance.
SQA (Society of Quality Assurance) Memeber
2010 to Present
Southern Regional Chapter Board of Directors member since 2013
GLP, EPA GLP, and Beyond Compliance Specialty Sections member
Areas of expertise include
• Good Laboratory Practices (GLP)
• Quality Assurance
• Supplier and Internal Audits / Surveillances
• Staff supervision and training
• Instrument Calibration
• Computer and Spreadsheet Validation
• Instrument Qualification / Acceptance / Validation
• Client / Federal Audit Hosting
• Corrective Action Tracking