Nicole Cruz Gonzalez
Quality Specialist
Needham,MA
Summary
Competent Quality Specialist with five (5) years of experience in the biotechnological and pharmaceutical field. Proven record of quality leadership in all facets of a quality environment. I aim to leverage my educational background and professional expertise in a dynamic environment. My goal is to contribute as a Quality Specialist in a production setting, particularly within a leading pharmaceutical company.
Overview
3
3
years of professional experience
Work History
QC Sample Management
Moderna
Norwood, MA
10.2022 - Current
- Coordinated sample management across functions, ensuring efficient processing and distribution
- Authored and supported quality records, including deviations, change controls, and CAPAs
- Managed domestic and international shipments and maintained compliance with cGMP documentation
- Performed AQL visual inspections and supported stability program operations.
- Managed and build cGMP Stability study pulls, protocols for mRNA Drug products, linearized plasmids and lipid nanoparticles.
Sampling and Monitoring Technician
Amgen
Juncos, P.R.
11.2021 - 10.2022
- Conducted environmental monitoring and managed sample lifecycle from collection to reporting
- Maintained instrumentation and supported continuous improvement through deviation and CAPA processes.
- Prepared bacterial samples for identification by PCR techniques.
Associate Quality Control
Amgen
Juncos, P.R.
06.2021 - 11.2021
- Executed quality control activities including water testing and sample/data management
- Upheld process integrity and compliance with safety and cGMP guidelines.
Quality Assurance Inspector
Medtronic
Juncos, P.R.
09.2020 - 06.2021
- Inspected quality of products and materials, documenting issues and corrective actions
- Contributed to the development and maintenance of training programs for production teams.
Education
Bachelor of Science - Biology
Interamerican University of P.R.
San Juan , PR06-2020
High School Diploma -
Steinmetz College
Skills
- Expert attention-to-detail and accuracy
- Data first mindset, presentation and communication of research findings
- cGMP, Quality Assurance, Quality Control and Technical documentation expertise
- Team capability acceleration, proven experience of leading high-performing teams Capable of working under pressure and meeting deadlines, both independently and in a team
Systems Technology
- Bilingual in English and Spanish.
- Competent in data entry and good documentation practices.
- Proficient in LIMS, LMS, FactoryWorks, CIMS, BlueMountain, Workday, and Microsoft Office Suite.
- Strong multitasking, analytical, and problem-solving abilities.
Languages
English
Professional
Spanish
Native/ Bilingual
Accomplishments
- Recognition from Moderna VP for support setting down Stability Study mRNA-3705 (UDP-200-BMMA).
Timeline
QC Sample Management
Moderna
10.2022 - Current
Sampling and Monitoring Technician
Amgen
11.2021 - 10.2022
Associate Quality Control
Amgen
06.2021 - 11.2021
Quality Assurance Inspector
Medtronic
09.2020 - 06.2021
Bachelor of Science - Biology
Interamerican University of P.R.
High School Diploma -
Steinmetz College
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