Lisa Smith Email & Phone Number

Dallas, Texas, United States

Director of Quality, Compliance and Safety, Arbor Women’s Health | Dallas, TX April 2021 – CurrentDirector position leading a team of Quality Specialists in a privately-owned full-service clinical laboratory operating in multiple states.• Regulatory inspection preparation for 2 on-site and 2 self-inspections including regulation review, procedure updates, conduct or lead inspections and all follow-up activities.• Updated the validation procedures to include a more efficient… Show more Director of Quality, Compliance and Safety, Arbor Women’s Health | Dallas, TX April 2021 – CurrentDirector position leading a team of Quality Specialists in a privately-owned full-service clinical laboratory operating in multiple states.• Regulatory inspection preparation for 2 on-site and 2 self-inspections including regulation review, procedure updates, conduct or lead inspections and all follow-up activities.• Updated the validation procedures to include a more efficient better documented process. Managed 74 new/updated tests and 5 new instrument validations/• Developed and implemented several new processes to streamline QMS systems such as Nonconforming Event Investigations, Proficiency Testing Investigations, Vendor Notifications.• Responsibilities include manage quality group, administrator for multiple s/w systems, create annual metrics, state physician licensing management, convert paper processes to electronic processes. Show less

San Diego, California, United States

Quality Assurance Specialist 3, Grifols Diagnostics Solutions Inc. | San Diego, CA May 2018 – April 2021Drive quality improvements in collaboration with management of quality and manufacturing departments. Identify root causes through extraction and analysis of data by conducting complaint and quality investigations. Submit trend reports through compilation and presentation of metrics. Formulate and compose detailed analysis with regard to complaints, inquiries, deviations, and… Show more Quality Assurance Specialist 3, Grifols Diagnostics Solutions Inc. | San Diego, CA May 2018 – April 2021Drive quality improvements in collaboration with management of quality and manufacturing departments. Identify root causes through extraction and analysis of data by conducting complaint and quality investigations. Submit trend reports through compilation and presentation of metrics. Formulate and compose detailed analysis with regard to complaints, inquiries, deviations, and nonconformances, stability studies, change control, sequence reviews, customer survey results and reportable events for regulatory requirements, including risks and conclusions for IVDR regulatory submissions as well as annual FDA submissions. Facilitate completion of audit procedures through audit preparation, conduct and audit responses.• Gained complainants’ satisfaction by ensuring complaint resolution through optimization of processes and procedures related to complaints. Participated in national and global complaint resolution meetings.• Improved employee productivity by providing leadership direction to team of three members.• Enhanced personnel understanding about systems and procedures by updating as well as delivering effective training sessions, with local and off-site direct reports. Show less

San Diego, California, United States

Manager Operations Microbiology - Optimized operational efficiency by administering and overseeing all aspects of production schedules, product transfer, quality documents, batch reviews and audit labs/processes, vendor as well as regulatory inspections, performance reviews, interview, recruitment, and metrics including inventory levels and quality measures.• Directed a team of ten personnel in Quality Micro and Production Micro teams.• Led and executed multiple projects, including ISO… Show more Manager Operations Microbiology - Optimized operational efficiency by administering and overseeing all aspects of production schedules, product transfer, quality documents, batch reviews and audit labs/processes, vendor as well as regulatory inspections, performance reviews, interview, recruitment, and metrics including inventory levels and quality measures.• Directed a team of ten personnel in Quality Micro and Production Micro teams.• Led and executed multiple projects, including ISO 13485 Risk Analysis updates, Training System Division Super user, and 3rd Party Proficiency Testing Program.• Ensured evaluation of SOP changes, execution of CAPAs, batch reviews, NCEs, and Process Deviations as well as engaged in Product Core Teams.Scientist 3 - Customer complaint investigator and process/product improvements.• Implemented and promoted actions to mitigate risks as well as resolved customer complaints by performing nonconformance investigations.• Collaborated with manufacturing and research departments to effect improvements.• Regulated continuous improvements by leading Product Support, Assay associates. Show less

Boise, Idaho, United States

Implemented new technology and adhered to regulations through analysis as well as approval of SOPs and validations. Managed and streamlined budgeting and outbreak testing processes by partnering with federal, state as well as local agencies.● Performed 150+ unique low to high complexity tests for clinical section of state public health laboratory by directing team of nine personnel.● Secured a total amount of $1.25M by budgeting and monitoring eleven state as well as federal grants.

El Centro, Ca

Supervised a team of 5 personnel and performed testing at a county public health laboratory. Assured compliance to state and federal regulations. Improved quality by implementing peer review, an incident report system, standardized SOPs and coordinated regulatory inspections. Collaborated with other departments, state agencies and the CDC during outbreaks. Manage employee performance reviews.

Imperial, Ca

Part time adjunct college professor of Microsoft Excel and Word teaching students with a wide variety of abilities.

Greater San Diego Area

Started as a manufacturing associate in the tissue culture lab. As my responsibilities increased, I was promoted into Quality Assurance as a Compliance Specialist performing internal and external quality audits. Further promoted to a Quality Engineer position where my duties included performing failure investigations to determining root cause, report writing, and developing and tracking corrective actions. Additionally tasked with assessment of the products and processes to develop and… Show more Started as a manufacturing associate in the tissue culture lab. As my responsibilities increased, I was promoted into Quality Assurance as a Compliance Specialist performing internal and external quality audits. Further promoted to a Quality Engineer position where my duties included performing failure investigations to determining root cause, report writing, and developing and tracking corrective actions. Additionally tasked with assessment of the products and processes to develop and implement improvements in quality and efficiency in addition to cost savings. Develop and evaluate metrics on quality systems. Show less

Bachelor Of Science - Bs, Medical Microbiology And Bacteriology

Mba, Technology Management