Marquise Lee Email and Phone Number

• Review and audit laboratory data for GCP and GLP (including Phase 3 clinical trials) studies including Run data, data tables, final reports and raw data generated in the lab. • Plan, schedule, conduct, report, and close audit activities in any of the countries involved with IQVIA contracts to assess compliance with applicable regulations/guidelines, customer requirements, Standard Operating Procedures (SOPs) and project specific guidelines/instructions. • Evaluate audit findings to prepare and distribute reports to operations staff, management, and customers.• Plan, schedule and conduct Vendor Assessments on a quarterly and annual basis. • Provide interpretation and consultation to project teams on regulations, guidelines, compliance status, systems compliance and policies and procedures.• Host audits/inspections, ensure proper conduct of customer-initiated audits, mock regulatory inspections, and assist in regulatory facility inspections. May perform GLP Archivist duties where needed.• Manage Quality Issues.• Review, approve investigations, Root Cause Analysis (RCA), Corrective Action Prevention (CAPA) and Effectiveness Check (EC) plans. Track until closure for quality events arising from Quality Issues, Audits, Inspections or during similar QA activities.• Present educational programs and provide guidance to operational staff on compliance procedures.• Evaluate policies and procedures for compliance with applicable regulations/guidelines and provide recommendations to management for continuous process improvements.• Assist in training of new Quality Assurance staff.• Support in QA initiatives/projects for quality, process improvements.• Manage/oversee quality events updates in eQMS.• Maintains the electronic quality management system (eQMS) and provides support in relation to the audit lifecycle.

• Conducts testing on commercial vaccine products and raw materials using Karl Fischer Coulometric Titration, Spectrophotometry, and pH testing. • Assist in the validation of quality control testing for new vaccine drug substances. • Revival and passage of Per.C6 TetR Control Cells for and testing of Cytopathic Effect (CPE), morphology and hemadsorption (HAD), cell density and viability confirmation using Vi-CELL BLUE Cell Viability Analyzer and ID PCR using the Bio-Rad S1000 Thermal Cycler PCR Machine and Bio-Rad PowerPac Basic for Gel Electrophoresis. • Test Record Review, execution of root cause analysis, technical writing such as SOP writing and editing, Quality Notifications and CAPA’s.

• Perform complex laboratory analysis of plasma and plasma products in a GMP laboratory.• Responsibilities include sample accessioning, sample preparation, reagent preparation, testing, result calculation, as well as quality control of assays and equipment.• Support assay validation, method transfer, reagent and control qualification, and laboratory maintenance activities as assigned• Use skills as a Subject Matter Expert to train new team members

• Perform complex laboratory analysis of plasma and plasma products in a GMP laboratory.• Responsibilities include sample accessioning, sample preparation, reagent preparation, testing, result calculation, as well as quality control of assays and equipment.• Support assay validation, method transfer, reagent and control qualification, and laboratory maintenance activities as assigned• GMP laboratory cleaning duties and housekeeping.

• Determines donor suitability to undergo plasmapheresis procedure including set up, disconnect, and operation of the automated plasmapheresis machine.• Assists in the plasma collection process under the supervision of a certified employee and in compliance with Standard Operating Procedures Manual guidelines.• Maintain familiarity and compliance with all state and federal regulations, FDA-approved Standard Operating Procedure Manual, OSHA, CLIA, cGMP and internal company procedures.• Trained in Phlebotomy

Obtain ID’s from registered votersExpress the views of Working America accurately

Teach at risk adolescence in Durham County, NC about the risks of underage drinking and alcohol abuse.

Instruct and facilitate STEM topics to homeschool students and teens. Perform and demonstrate various biology and chemistry concepts through experiments.

- write and instruct science lessons on the 3rd to 8th grade level- conduct science experiments- chaperone camp members- assist camp directors

- Meticulously unpack and process store merchandise- Implement company guidelines to uphold the highest store standards- Help with customer assistance

~Responsible for training new student assistants~Created and modified props for theatrical productions~Designed and set up tables for fundraising events and balls