Yyyyyy x. yyyyyy

Senior Quality Assurance Auditor

Laboratory Operations ~ SOP & GLP Compliance ~ Staff Training & Leadership

         Highly skilled at orchestrating all aspects of QA operations encompassing client relations, data analysis, audits, compliance, documentation, and equipment qualification.

         Possess a strong blend of managerial, analytical, organizational, supervisory, and administrative skills.

         Highly collaborative with advanced talents in lab/process controls, labeling, safe handling, and auditing complex bioanalytical and clinical pathology reports.

         Proficiency in using, calibrating, and maintaining common lab equipment and instrumentation including automated QA records management systems.

         Proven ability to understand and communicate scientific information, work in cross-disciplinary teams, and handle project tasks independently according to demanding schedules and budgets.

Southern Research Institute, Frederick, MD, 2009 to 2015

Senior Quality Assurance Auditor (2015)

Advanced Quality Assurance Auditor (2009 to 2015)

         Governed regulatory compliance of all projects according to 21 CFR Part 58 by conducting in-process audits, maintaining master schedule, and verifying protocols, equipment qualification plans, and validation plans.

         Examined data, reports, and facilities to ensure compliance with SOPs and applicable regulations.

         Hosted QA visits from client facilities and co-hosted regulatory inspections with Director of Quality.

         Championed efforts for lab to receive clearance for unescorted access into BSL-3 containment area.

         Trained, instructed, and mentored new personnel in GLP.

         Actively served on company s Computer System Validation Committee.

Charles River Laboratories, Pathology Associates, Frederick, MD, 2004 to 2009

Senior Quality Assurance Auditor

         Steered compliance of all projects with 21 CFR Part 58 criteria by conducing in-process audits, closely reviewing SOPs, inspecting facilities, and scrutinizing high-volume data and reports.

         Scheduled and hosted QA visits from client facilities, and hosted or co-hosted FDA inspections onsite.

         Delivered comprehensive GLP training to new hires in order to achieve and sustain strict QA targets.

Charles River Laboratories, Pathology Associates, Frederick, MD, 2000 to 2004

Supervisor, Plastics and Medical Device Laboratory

         Spearheaded full-scope laboratory operations including prioritizing, scheduling, and supervising activities such as x-raying of specimens, operating EXAKT system to prepare plastic embedded samples, and embedding soft tissue samples in resin.

         Consistently aligned studies with GLP regulations to optimize reliability, quality, and integrity.

Continued

Professional Experience continued Yyyyyy x. yyyyyy Page 2 of 2

SAIC, Pathology Associates, Frederick, MD, 1998 to 2000

Immunopathology Technician

         Performed staining of slides for cross-reactivity studies within a GLP-compliant facility and documented findings.

         Expertly used cryostat device to section and preserve frozen tissue samples.

Pathology Associates, Frederick, MD, 1985 to 1998

Teratology Technician

         Planned, coordinated, executed, and regulated Special Developmental and Reproductive Toxicology (DART) studies in precise alignment with facility SOPs and GLP protocols.

         Administered rodent and rabbit C-sections, collected fetal data using Artemis II data capture system, and prepared skeletal systems for in-depth evaluation.

         Extensively operated Hamilton-Thorne IVOS sperm analyzer at client facilities and onsite.

Pathology Associates Inc., Ijamsville, MD, 1985 to 1995

Senior Histotechnician / Group Leader of Quality Control

         Enforced quality control of all electron microscopy samples and actively participated in troubleshooting of histology equipment to effectuate flawless performance and functioning.

         Facilitated clients SMVCE programs and provided necropsy support to clients including National Institute of Environmental Health Sciences.

Prior background includes role as Histotechnician at Frederick Cancer Research Facility in Frederick, Maryland.

Completed ongoing and extensive training in areas spanning viruses, bacteria, bloodborne pathogens, radiation, hazardous/medical waste management, biosecurity, emergency response, FDA Part 11 inspections, bioanalytical auditing, validation process, quality systems, scientific investigations (FDA), risk management and drug surveillance (FDA), electronic data and validation, electronic QA records, change control, Provantis software, Good Documentation Practices, quality assurance records management, NIH information security awareness, and more.

RQAP-GLP

HT (ASCP)

American Society of Clinical Pathologists

Society of Quality Assurance

National Capitol Area Region of Quality Assurance