Nafisa Nusha Email & Phone Number

Greenville, NC, US

Columbia, Missouri, United States

• Serves as the lead QA for Bioanalytical Laboratory Audits. Performs audits of Analytical Method Validation Plan/Report and sample analysis for regulated studies for Biomarkers, ADA, LBA, Immunogenicity, Flow Cytometry.
• Provides QA support to Computer System Validation (CSV) activities. Audits validation deliverables included but not limited to: Validation Protocol, System Requirements, System Configuration Specifications, IQ/OQ/PQ.
• Conducts periodic risk-based internal facility and process based inspections.
• Performs data review and audits for Toxicology and Safety Pharmacology studies.

Columbia, Missouri, United States

• Maintains competency in the current Good Laboratory Practices (GLP) regulations and Standard Operating Procedures (SOPs).
• Reviews new and revised SOPs to ensure compliance with regulatory agencies as well as identifies and recommends the need for additional SOPs.
• Ensures thorough data inspections of SOPs and conduct of study being practiced.
• Performs periodic study audits and/or facility audits.
• Audit in-life procedures to ensure compliance with GLPs, SOPs and protocols.

Morgantown, West Virginia, United States

• Served as a subject matter expert in multiple REMS (Risk Evaluation and Mitigation Strategy) program and worked in collaboration with program manager to attain all program goals.
• Managed and monitored daily activities for a team of 10+ people to ensure all project tasks are completed to meet client expectations.
• Worked as the first point of contact for other Coordinating Center Associates for any program escalations as part of the leadership team.
• Conducted project team meetings to ensure associates are informed of changing policies and procedures and escalated concerns to upper management team.
• Was responsible for training and mentoring of all new hires and existing associates as necessary as well as creates and updates training materials and project specific procedures.
• Participated in the interview and evaluation process.

Morgantown, West Virginia, United States

• Provided consistent customer service support to all stakeholders for the assigned programs by handling inbound and outbound contacts from various sources.
• Conducted communication with stakeholders to retrieve data or to address discrepancies in data received by completing full follow up including data entry process, documentation and safety reporting.
• Ensured all program compliance duties including re-education of stakeholders, documentation of non-compliant event, and healthcare provider follow-up are completed

Morgantown, West Virginia, United States

• Investigated the role of histone modifications in metastatic triple negative breast cancer to identify potential target genes and modifications in cancer therapy.
• Conducted western blot analysis and chromatin immunoprecipitation to identify differentiation of chromatin modification in different human cancer cell lines.
• Demonstrated localization of proteins and related chromatin modifications in breast cancer cell lines using immunofluorescence imaging analysis
• Maintained and manipulated human and mouse cancer cell lines using clonal selection, recombinant plasmid cloning and viral transfection.