Victor Vincent Email and Phone Number

Perform Quality Assurance real time through final product review of commercial and clinical trial medical device unit documentation during manufacturing campaigns and prepare batch record for final disposition; Oversee line and area clearance approval during changeover process, reconciling components and products, investigating discrepancies and elevating issues to manufacturing and QA management when necessary; Investigate potential non-conformities, track weekly/monthly cleanroom area environmental monitoring data and review sterilization reports; Inspect medical devices, including incoming components and WIP samples; Utilize sample retention and product release activities and serve as point of contact for Quality sample submission request.

Provided quality review and disposition of site GMP documentation (Paper and Electronic Based batch records, log books and batch process reports) related to the operation of aseptic vaccine drug substance manufacturing and authored site complaint investigation reports for adverse events. Performed personnel qualifications and walk-thru audits for product changeover of manufacturing Shop Floor area.

Technical Development of Release and Characterization Assays in support of Flu vaccine processes and product development.

Authored and reviewed investigational protocols/reports, change control request. Performed release and stability testing of large molecule products in support of Therapeutic Biologic manufacturing. Communicated with the Supervisor/Manager regarding cGMP compliance and identification of issues and/or corrective actions on the laboratory floor.

Performed technical review of data and analytical testing of drug substance/API, medical devices, Release/Stability drug products, and excipients utilizing current USP/NF, Ph. Eur, and JP compendia methods; Authored Certificates of Analysis and initial Lab Investigation Reports (LIR) as related to OOS and aberrant data generated during analytical testing.

Performed in-process and final product analytical assays and relayed test results to Solution Operators in a timely manner; Trained new analysts on In-Process and Final Product testing; Retested products with Out Of Specification results to assist with the prompt release of investigations; Troubleshoot and help resolve any issues as they arise during various stages of testing to ensure production is not hindered and product quality is not jeopardized.

Performed inspection of Food and Lodging Facilities, Pools, Schools and other state institutions according to the established rules and regulations of North Carolina.

TAUGHT HIGH SCHOOL ALGEBRA I AND TECHNICAL MATH IN ACCORDANCE TO THE NORTH CAROLINA DEPARTMENT OF PUBLIC INSTRUCTION; MAINTAINED STUDENT RECORDS, SCHEDULED CONFERENCES AND PROVIDED REINFORCEMENT FOR SUBJECT MATTER; ATTENDED MONTHLY PROFESSIONAL DEVELOPMENT MEETINGS PROVIDED FOR ALL FIRST YEAR FACULTY; COACHED GIRLS’ BASKETBALL AND CO-ED TRACK AND FIELD.