Maya Zelmanovich
San Diego,USA
Summary
Committed Senior Project Engineer with strong project design and proven leadership skills. Diligent in delivering successful projects by fully assessing established goals and creating a precise plan accordingly. Detailed in maintaining communication with team leaders until project completion and reporting with accuracy to meet regulatory requirements.
Overview
5
5
years of professional experience
Work History
Senior Project Engineer I
Project Farma
San Diego, CA
07.2022 - Current
- Author and execute technical documents and protocols for GMP laboratory systems throughout the CQV lifecycle
- Systems range from process to computerized analytical equipment
- Perform asset management and coordinate calibration/maintenance of GMP lab equipment
- Assist in the development of an engineering study that minimizes deviations within QC laboratories
- Document, investigate, perform impact analysis and remediate deviations initiated within Quality Control and Engineering departments
- Provide process support for QMS systems
- Perform risks assessments for systems and provide risk mitigations
- Lead meetings with stakeholders and cross-functional teams to review management and execution of processes and protocols for CAPA's and Change Controls
- Assist in the development and implementation of efficient internal project management tools and methodologies.
Undergraduate Researcher
NCSU Department of Food Science
Raleigh, NC
10.2021 - 06.2022
- Designed the method for the research project: Understanding the Differences in Staphylococcal Enterotoxin Levels Between Mastitic and Non-Mastitic Human Breast Milk
- Performed bacterial cell culture and cell count of Staphylococcal aureus
- Tested human breast milk for Staphylococcal enterotoxins using ELISA (enzyme-linked immunosorbent assay)
- Presented test methods and data to the principal investigator.
Project Management Intern
United Natural Hemp Extracts
Wilson, NC
06.2021 - 08.2021
- Developed and maintained project plans, timelines, and development product profiles in collaboration with team leaders
- Reviewed and edited labels and packaging of CBD products, ensuring FDA and FTC compliance
- Managed the company’s application and documentation submittal for GMP certification.
Medical and Life Science Division Intern
Fourstar Group
Shenzhen, China
06.2019 - 08.2019
- Reviewed manufacturing procedures and documentation for over-the-counter medications and cosmetics
- Developed a corporate training curriculum for new associates covering packaging and labeling standards for over-the-counter drugs and cosmetics, and FDA testing and approval for class I medical devices
- Conducted training seminars in China for the Asian Life Sciences Division on FDA rules and regulations for over-the-counter drugs, class I medical devices and cosmetics.
Education
B.S in Biological Sciences: concentration in Molecular, Cellular, and Developmental biology. Minor in Microbiology -
NORTH CAROLINA STATE UNIVERSITY
05.2022
Skills
- Proficient in Microsoft Excel, Word, and PowerPoint, SharePoint and EDMS (Veeva Vault)
- Proficient in GxP
- Knowledge of 21 CFR 11, 58, 312, 820
Citizenship
Dual Citizen: USA, EU
Timeline
Senior Project Engineer I
Project Farma
07.2022 - Current
Undergraduate Researcher
NCSU Department of Food Science
10.2021 - 06.2022
Project Management Intern
United Natural Hemp Extracts
06.2021 - 08.2021
Medical and Life Science Division Intern
Fourstar Group
06.2019 - 08.2019
B.S in Biological Sciences: concentration in Molecular, Cellular, and Developmental biology. Minor in Microbiology -
NORTH CAROLINA STATE UNIVERSITY
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