Paulina Wells
College Station
Summary
Accomplished Quality Assurance Analyst with a PhD degree specializing in regulatory compliance and audit management. Demonstrated expertise in drafting quality documents and improving quality systems, supported by strong project management capabilities. Proficient in molecular biology and chemistry techniques, ensuring precision and excellence in laboratory operations.
Overview
7
7
years of professional experience
Work History
Quality Assurance Analyst III
Fujifilm Diosynth
07.2023 - Current
- Reviewed and approved a variety of documentation, including Standard Operating Procedures (SOPs), completed and draft Batch Production Records, commissioning/qualification/validation protocols and reports, deviation reports, CAPA plans, and technical and QC data.
- Drafted and reviewed internal quality policies, procedures, and compliance reports.
- Inspected final product containers and reviewed and/or approved executed process records and associated data.
- Performed quality audit functions such as reviewing laboratory logbooks, assessing vendor/supplier/contract laboratory audit questionnaires, and leading audits of vendors, suppliers, contract laboratories, and clients.
- Identified opportunities to improve processes and the overall Quality Management System.
- Provided daily guidance to ensure QA department compliance with national and international regulations and standards.
- Supported both regulatory and internal audits through documentation, preparation, and participation.
- Acted as the primary QA liaison for internal departments, client quality groups, and vendor/contract laboratory quality teams.
- Served as the QA point of contact for a key client, maintaining consistent communication and issue resolution.
- Managed QA operations and resource allocation for one of the company’s production departments.
Biological Scientist
Cherokee Federal
01.2023 - 07.2023
- Drafted Standard Operating Procedures (SOPs) and batch records in full compliance with FDA 21 CFR Part 58 Good Laboratory Practice (GLP) regulations, including qualification of laboratory reagents for quality assurance.
- Conducted laboratory research involving cloning and synthesis of HA and NA genes into CDC-provided or approved reverse genetics vectors for virus rescue, ensuring plasmid preparation met GLP standards.
- Evaluated and optimized HA and NA constructs prior to the rescue of each GLP-compliant Candidate Vaccine Virus (CVV) in both BSL-2 and BSL-3 laboratory environments.
- Performed a range of laboratory assays, including antigenicity testing, hemagglutination (HA) assays, and Egg Infectious Dose 50 (EID50) assays to assess viral characteristics.
- Contributed to scientific meetings by presenting research updates, engaging in troubleshooting discussions, and delivering reports to the CDC CVV team.
- Assisted in the preparation for and execution of both internal and external audits to ensure regulatory compliance and quality standards.
Laboratory QC Analyst
JOTIS SA/HRIC
08.2018 - 11.2019
- Conducted quality control testing of company products using diverse microbiological methods, including DNA extraction for GMO analysis and RT-PCR for quantifying GMO genetic elements.
- Applied ELISA techniques for detecting allergens and aflatoxins in food products and on surfaces.
- Investigated incidents of microbial contamination to identify sources and implement corrective actions.
- Performed microbiological shelf-life assessments to ensure product stability and safety.
- Utilized mini VIDAS and 3M MDS systems for the detection of foodborne pathogens such as Salmonella spp. and Listeria spp.
- Operated within a Biosafety Level 2 (BSL-2) laboratory environment, adhering to all safety protocols.
- Participated in the laboratory accreditation process, contributing to compliance and quality standards.
- Supervised and trained a team of interns, managing daily laboratory activities, assigning tasks, and resolving technical issues.
- Maintained accurate documentation in accordance with Good Manufacturing Practice (GMP) requirements.
- Compiled and shared weekly performance feedback with team leaders and managers to enhance service efficiency, quality, and productivity.
- Effectively communicated research findings to stakeholders across industry, government, and the general public.
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 and staff mentoring
- Biosensor development
- Data analysis
- Good Laboratory Practice (GLP)
- Good Manufacturing Practice (GMP)
- Computer skills (MS Office, Origin, Photoshop)
- Microbiology, molecular bioology and chemistry techniques
- Validation of laboratory assays and methods
- Facility inspection
- Regulatory compliance
- FDA regulations
- Client communication
- Audit management
- Authoring peer-reviewed publications
Languages
Polish
Native or Bilingual
English
Native or Bilingual
Greek
Professional Working
German
Elementary
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
Master of Science - Biotechnology
University of Opole
Bachelor of Science - Biology, spec. Microbiology
University of Wroclaw
Ph.D. - Chemistry
Clarkson University
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