Delisa Davis Email & Phone Number

Rockville, Maryland

• Assist in leading facility inspections audits. • Identify areas in need of quality improvement within various departments.• Advise management (operations) and staff of their role regarding quality responsibilities, systems, or problems.• Recommend policy changes, adjustments, or resources for specific circumstances.• Familiar with co-hosting client visits and regulatory inspections.• Capable of performing vendor/subcontractor audits.• Assist in developing and… Show more • Assist in leading facility inspections audits. • Identify areas in need of quality improvement within various departments.• Advise management (operations) and staff of their role regarding quality responsibilities, systems, or problems.• Recommend policy changes, adjustments, or resources for specific circumstances.• Familiar with co-hosting client visits and regulatory inspections.• Capable of performing vendor/subcontractor audits.• Assist in developing and documenting corrective action plans (CAPA).• Plan, conduct and report study-specific laboratory inspections to assess compliance with GLP regulations/industry standards.• Aide in the planning, development, and delivery of comprehensive GLP training programs as needed.• Ensure the safety, quality, and effectiveness of pre-clinical trials supports the protocol and appropriate regulations. • Understand and interpret applicable regulations.• Possess basic scientific knowledge of the audit scope.• Serve as the on-site Safety Representative. Show less

Rockville, Maryland

● Working knowledge of cGMP.● Implemented department policies for the QA unit such as computer system validation and training requirements.● Assisted the QA Supervisor and/or QA Director with planning, developing, and managing the Toxicology QA unit as it relates to the mammalian toxicology program.● Reviewed protocols, raw data, and data summary tables for nonclinical studies conducted by BREL to evaluate regulatory compliance.● Provided QA program assistance and/or advice to… Show more ● Working knowledge of cGMP.● Implemented department policies for the QA unit such as computer system validation and training requirements.● Assisted the QA Supervisor and/or QA Director with planning, developing, and managing the Toxicology QA unit as it relates to the mammalian toxicology program.● Reviewed protocols, raw data, and data summary tables for nonclinical studies conducted by BREL to evaluate regulatory compliance.● Provided QA program assistance and/or advice to operations or various departments regarding development, production, use, storage, documentation of protocols, electronic systems, and equipment in accordance of GLPs and SOPs.● Assured QA departmental inspection reports and any supporting documentation or required records were appropriately processed and archived.● Identified regulatory compliance issues and provided regulatory support to BREL departments.● Possess an understanding of worldwide GLP regulations (EPA, FDA, OECD, and ● Maintained schedule of all GLP study assignments, timelines, and departmental requirements by effectively communicating with operations and various departments.● Aided in implementing department policies by inspecting protocols, in-process phase inspections, required personnel training, document management, and workplace safety.● Provided training to quality assurance personnel.● Monitored and evaluated the accuracy of validated equipment and the competency of personnel by conducting regulatory phase inspections.● Assisted in initial face to face GLP training to new hires.● Collaborated on the validation of the Provantis electronic data collection system to assure that the system accomplishes its intended purpose.● Tracked trending of GLP deviations of multiple departments to provide assessment information to operations. Show less

Rockville, Maryland

● Reviewed, implemented, and analyzed pre-clinical animal studies in keeping with established pharmaceutical research protocols and laboratory regulations.● Managed the Toxicology Department in the absence of the lab supervisor to include coordination and facilitation of staff meetings.● Trained and mentored approximately 7-10 junior staff members on computer laboratory data management systems and laboratory technical skills.● Coordinated individual and team schedules and clinical… Show more ● Reviewed, implemented, and analyzed pre-clinical animal studies in keeping with established pharmaceutical research protocols and laboratory regulations.● Managed the Toxicology Department in the absence of the lab supervisor to include coordination and facilitation of staff meetings.● Trained and mentored approximately 7-10 junior staff members on computer laboratory data management systems and laboratory technical skills.● Coordinated individual and team schedules and clinical research tasks.● Conducted interviews of prospective laboratory candidates for hire.● Abate, report, and document maintenance problems with laboratory equipment to prevent interruption or delay in completion of clinical pharmaceutical research studies. ● Expertly packaged, labeled, shipped, and tracked shipping of laboratory samples from beginning to final destination● Served as essential laboratory personnel and willingly cross trained in other clinical departments to provide clinical assistance. ● Performed, documented, and maintained quality control of clinical research data and address audit findings.● Set up pre-clinical trial studies using Provantis Data Management System ● Ordered and purchased laboratory supplies as needed.● Inspected laboratory work areas and updated the daily Laboratory Walk-Thru Log. ● Record accurate pre-study initiation meeting minutes for dissemination to various departments and serve as liaison in professional meetings.● Developed a spreadsheet that trended overtime hours for management.● Organized, maintained, and monitored stockroom inventory to prevent waste and abuse of company supplies.● Archived previous year facility essential forms for easy access and retrieval.● Proficiently draw and process blood assay samples and prepare blood smear slides as needed for clinical pharmaceutical trials. Show less