Paulina Wells
College Station
Summary
Dynamic Quality Assurance Analyst with extensive experience and a PhD degree, excelling in regulatory compliance and audit management. Proven track record in drafting quality documents and enhancing quality systems, coupled with strong project management skills. Adept in molecular biology techniques, ensuring high standards in laboratory practices.
Overview
8
8
years of professional experience
Work History
Quality Assurance Analyst III
Fujifilm Diosynth
College Station
07.2023 - Current
- Reviewing and/or approving documentation to include, but not limited to: Standard Operating Procedures, Batch Production Records (completed and drafted), Commissioning, qualification and validation protocols and reports, Deviation Reports, Corrective Action/Preventive Action Plans, Technical data review and approval, QC data review and approval
- Drafting and reviewing internal Quality policies, procedures, and reports
- Performing inspections of final product containers and review and/or approval of executed process records and data
- Performing Quality audit functions to include, but not limited to: Audit of lab logbooks, Review of vendor, supplier, contract laboratory audit questionnaires, Lead vendor, supplier, contract laboratory and client audits
- Identifying process and Quality System improvement opportunities
- Providing daily guidance for the compliance of the QA department to national and international standards and regulations
- Supporting Regulatory and internal audits
- Acting as QA liaison to internal Departments and external Client Quality Groups and Vendor/Contract Laboratory Quality Groups
- QA point of contact for one of the company’s clients
- Managing QA activities and resources for one of the production departments
Biological Scientist
Cherokee Federal
San Antonio
01.2023 - 07.2023
- Developing draft SOPs and batch records in strict accordance with FDA's 21 CFR 58 GLP regulations, including quality assurance qualification of all laboratory reagents
- Performing laboratory research that included cloning or synthesizing the HA and NA genes into CDC provided/approved reverse genetics vectors compatible for virus rescue and prepare high quality plasmids in compliance with GLP regulations
- Performing laboratory research to determine the optimal HA and NA constructs before rescuing each of the GLP-CVV in BSL-2 and BSL-3 level laboratories
- Performing variety of laboratory tests such as antigenicity testing, hemagglutination assays (HA), Egg Infectious Dose 50 (EID50) assays
- Supporting scientific meetings that included troubleshooting discussions, providing research updates and reports to the CDC CVV (Candidate Vaccine Virus) team
- Supporting internal and external audits
Laboratory QC Analyst
JOTIS SA/HRIC
Athens
08.2018 - 11.2019
- Performing quality control of company products using various techniques for identifying microorganisms; DNA extraction procedures for GMO; quantitative screening of GMO genetic elements using RT-PCR; ELISA techniques for detection of allergens, aflatoxins on food products and surfaces
- Investigation of microbial contamination incidents
- Microbiological shelf-life determination
- Using mini VIDAS and 3M MDS methods for pathogens identification (Salmonella spp, Listeria spp)
- Working in BSL-2 safety level laboratory
- Taking part in accreditation procedure
- Managing a group of interns (performing training, organizing daily work in the laboratory, dividing tasks, troubleshooting)
- Documenting work as required for GMP compliance
- Compiled and distributed weekly feedback to team leaders and managers to improve service time and quality while increasing productivity
- Communicating research results to individuals in industry, government, and general public
Summer Research Intern
National Hellenic Research Foundation
Athens
05.2017 - 09.2017
- Supported research and development efforts to create new products, equipment, and processes
- Details: taking part in research, concerning nanoformulation of microemulsions to be used as matrices for enzyme encapsulation
- System could be used as biocatalyst to perform synthetic reactions
- Program was composed by preparation of microemulsions based on various surfactants; encapsulation of lipase in dispersed water pools; carrying out of esterification reactions followed via GC chromatography
Education
Ph.D. - Chemistry
Clarkson University
Potsdam, NY05.2022
Master of Science - Biotechnology
University of Opole
Opole, Poland06.2018
Bachelor of Science - Biology, spec. Microbiology
University of Wroclaw
Wroclaw, Poland06.2016
Skills
- Project and team management
- Student mentoring
- Biosensor development
- Data interpretation
- Good Laboratory Practice (GLP)
- Good Manufacturing Practice (GMP)
- Computer skills (MS Office, Origin, Photoshop)
- Molecular biology techniques
- Microbiology techniques
- Chemistry techniques
- Validation of laboratory assays and methods
- Facility inspection
- Document control
- Regulatory compliance
- Standard operating procedures
- FDA regulations
- Client communication
- Audit management
Timeline
Quality Assurance Analyst III
Fujifilm Diosynth
07.2023 - Current
Biological Scientist
Cherokee Federal
01.2023 - 07.2023
Laboratory QC Analyst
JOTIS SA/HRIC
08.2018 - 11.2019
Summer Research Intern
National Hellenic Research Foundation
05.2017 - 09.2017
Ph.D. - Chemistry
Clarkson University
Master of Science - Biotechnology
University of Opole
Bachelor of Science - Biology, spec. Microbiology
University of Wroclaw
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