Responsible for the creation of clear and concise documentation for diverse audiences. Responsibilities include translating complex technical information into user-friendly manuals, guides, and online resources.
• Created multiple SOPs and Job Aids as part of a manufacturing remediation initiative by collaborating with cross-functional teams, ensuring accuracy and consistency in product documentation.
• Worked together with multiple teams to help ensure greater overall GMP compliance over a period of less than 90 days.

Primarily responsible for investigations and timely solutions of excursions for major and minor deviations. Also responsible for performing root cause analysis investigations through the use of SPS tools.
• Closed multiple major and minor deviations over 30 days, successfully completing the requirements for certification. Currently supporting aseptic production teams, reviewing deviations,
performing root cause analysis investigations, and looking for ways to further optimize processes. Working alongside a diverse team of administrative staff, biomanufacturing specialists, and internal/external regulatory authorities to ensure that all deviations are closed in a timely manner.

Primarily manage and assist with review of deviations and investigations, review/revision of SOP's, release of materials, qualification of critical suppliers, review of product release, extensive review of batch records and fill finish production/oversight.
• Assisted with multiple manufacturing ramp-up initiatives, which required the development and quality review of numerous SOPs and Master Batch Records, the maintenance of deviations and Corrective and Preventive Actions, and extensive document control. Assisted with the oversight of daily inventory management logs and the execution/release of Environmental Monitoring collections. Significant contributions led to successful audits, higher overall quality of work, and the development of a new fill/finish program for our team at Duke Human Vaccine Institute.
• Ensured the successful initiation, execution, and close-out of multiple deviations and CAPAs, while maintaining good standing with ongoing manufacturing campaigns. Worked with

Hired into a temporary position to assist in manufacturing ramp-up, then quickly promoted within six months to a full time Manufacturing Associate I position. Primarily manage and assist in Enzyme-linked Immunosorbent Assay (ELISA) Development. Experienced in quality assurance, safety, laboratory documentation, and cGMP compliance.
• Supported an ongoing, months-long manufacturing ramp-up initiative, which required the development and quality control of countless ELISA devices, the oversight of daily inventory management logs, and the packaging of biochemical products for subsequent validation and distribution. Significant contributions led to a rapid promotion, multiple raises, and the finalization of additional contracted business opportunities for Avioq, Inc.
• Oversaw the successful initiation, execution, and close-out of multiple biomanufacturing audits. Worked with a team of administrative staff, biomanufacturing specialists, and internal/external regulatory authorities to ensu

Worked with team members to collect donations from alumni of the university while managing a full course load as a full-time student. Utilized various software, including Microsoft Excel, to catalog data appropriately and perform data quality control, ensuring that the correct contacts were assigned and documented properly.