Nzavi Wanyoike

Skills

Project/Time Management, Cross-functional, Attention to Detail, Communication (verbal/written), Problem Solving, Research, Flexibility/Adaptability, Troubleshooting, Leadership, Learning, MS Office, SharePoint, Outlook, Smartsheet.

Education

Saint Elizabeth University B.S Biology

Experience

Passage Bio, Inc. Hopewell, NJ

July 2022 – September 2023

Analytical Research Associate

Create and maintain paper-based inventory system for GMP, non-GMP, and retain samples.

Monitor and maintain stability inventory and perform stability shipments to CRO’s and/or sample storage vendors.

Prepare, package, label, and schedule samples for pick-up and delivery.

Perform stability timepoint pulls as per approved protocols.

Ensures compliance with cGMP requirements.

Participates and leads continuous improvements.

Build and manage a sample scheduling tool to plan and schedule all analytical testing.

Interface with all stakeholders to communicate and track against testing schedule.

Work with Materials Management to ensure consumables, buffers, and reagents are accurately inventoried/tracked/disposed at expiry.

Develop, optimize, and validate analytical methods for the analysis of small molecule drugs.

Interpreting data/reviewing, preparing, and presenting summarized results for internal and external members.

Collaborating with cross-functional teams to provide analytical support for numerous drug development programs.

Maintain laboratory equipment and records to ensure compliance with GMP/GLP regulations.

Participate in investigations and troubleshooting activities to resolve technical issues.

Maintaining the cell growth of RC32 cells in analytical development bioassay lab.

Participated in qualification of method assay (TCID50).

Provide tours and support audits as requested.

Sample Management/Tracking:

Receiving, verifying, distributing, documenting, and storing samples following SDS protocol.

Logging documents and forms in company’s inventory management system (LIMS).

Distributing/coordinating samples to appropriate personnel or testing facilities.

Compliance with relevant regulations and guidelines for sample handling and documentation.

Developing and implementing process to improve sample management efficiency and accuracy.

QDx Pathology Services Edison, NJ

November 2020 – July 2022

Molecular Lab Technologist

Conducting the extraction of Covid-19 nasopharyngeal swab tests/performing respiratory pathogen panel tests via RT-PCR on multiple platforms.

Conducted gastrointestinal pathogen panel tests and parasite analysis of stool samples via slide preparation and staining.

Maintaining sample tracking via company LIS and coordinating with local and national health departments to report “reportable pathogens” for communicable diseases via access to CDRSS, Faxage, and Health Commerce System (ECLRS).

Ensuring proper QA/QC and contamination tracking, lab decontamination, and prevention.

Training new hires and assisting in implementing polices and procedures.

Demonstrating knowledge of proper management and disposal of biohazardous waste, as well, as cleaning, maintaining, and setting up thermocyclers for heat lysis extractions

Client Services

Responding to client inquiries and concerns, by providing accurate and helpful information regarding laboratory services and procedures.

Troubleshooting issues that arise and working with the laboratory team to find effective solutions to problems.

Maintaining client records and ensuring confidentiality is always maintained.

Communicating effectively with clients, laboratory staff, and management to ensure that all clients receive the highest level of service.

Demonstrating a proactive approach to client services, identifying potential issues before they arise and talking steps to address them.

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