Alexis Richardson

• Independently manage and monitor the processing, review, and approval of revision- controlled documents in the Electronic Document Management System (eDMS).
• Provide user assistance and training on the eDMS.
• Ensure compliance with controlled document format and content.
• Maintain master documents and records (both hardcopy and electronic) to ensure documentation is retrievable

and files are accurate, complete, and well organized.

• Manage the document periodic review process.
• Provides support for internal and regulatory audits and inspections as required.
• Comply with Safety SOPs, SDS sheets, and laboratory procedures per company policy and OSHA regulations.
• Must adhere to Iovance Biotherapeutics’ core values, policies, procedures, and business ethics.
• Independently manage and monitor the review and approval of training tasks in the Electronic Document Management System (eDMS).

• Reviewed and approved GMP data generated by QC and contract testing organizations, ensuring compliance with regulatory and data integrity standards
• Collaborated with laboratory management and QA teams to ensure alignment with GMP / GDP requirements and data integrity policies
• Conducted thorough reviews of laboratory records, test results and electronic data (LIMS) for accuracy, completeness, and compliance with cGMP and internal SOPs
• Proactively addressed quality-impacting issues by communicating with analysts and laboratory managers and participating in cross-functional teams
• Supported internal and cross-departmental initiatives to resolve data-related issues and enhance overall data quality
• Ensured assay records and related information met test method, procedural and scientific standards for lot release and QC studies
• Contract (Actalent – Emerson Fluman)

• Leverage social media platforms (Instagram and Facebook) to organically connect with and meet potential clients
• Study and interpret social KPI’s that have helped me grow my social pages and connect with clients
• Prepare and coordinate closing gifts and pop-by’s for past clients
• Use programs such as Asana and Trello for project and transaction management
• Conduct market research and analysis to stay updated on market trends and property values
• Design and implement marketing strategies through email and digital marketing (use of Mailchimp, Flodesk, Zapier, Canva)
• Prepare CMA (comparative market analysis) reports to educate clients on property values
• Negotiate favorable terms and conditions on behalf of clients to achieve the best possible terms
• Coordinate property showings, open houses and property inspections
• Manage all paperwork, contracts, and documentation accurately and efficiently
• Provide administrative support, including answering phone calls, responding to emails and scheduling appointments

• Routine testing of biological assays
• Promoted within 12 months for exceeding performance expectations and delivering excellent, quality results.
• Lead and assisted with analytical validation projects at a level II which contributed to the team’s overall efficiency and success.
• Data entry and analysis using LIMS, Trackwise and PLA systems
• Provides timely review of GMP data and documentation generated for or by QC
• Performed GMP document revisions (SOPs and workflows)
• Participated in the execution of method/material qualification for various biological assay techniques.
• Responsible for sample pickup and inventory
• SME on multiple biological assays and responsible for training new team members
• Writing reports for IA (invalid assays) and deviations.
• Supports maintenance of laboratory systems and inventory of standards and reagents to ensure integrity of all laboratory results through LIMS database.
• Collaboration with cross-functional teams to execute testing and projects.
• 919-991-1100
• Supervisor: Lindsay Smith
• Full-time

• Perform routine research activities
• Carry and maintain a study load
• Dosing of laboratory animals via IP, PO, SC and IV
• Review protocols to ensure proper execution of studies
• Finalize study folders and ensure that all data is collected
• Centrifugation to process blood for plasma and serum
• Maintain laboratory equipment
• Drug formulation and prep sheet
• Responsible for reporting clinical observations of laboratory animals
• 919-462-8338
• Supervisor: Louis Dawson
• Full-time