MERIE SANTANA
Humacao
Summary
Seeking a challenging position in a progressively growth-oriented company where my experience and skills will contribute significantly to the success of the organization and provide opportunities for my career growth. Results-driven QA/Operation with almost 12 years of experience complex in the Pharmaceutical and Medical Device sectors. Expertise encompasses regulatory compliance, quality systems, and process improvement initiatives that enhance operational efficiency with regulations standards. Detail-oriented professional with experience in working on processes and procedures in accordance with quality standard and able to quickly adapt, work in teamwork to continue growing with the values of company.
Overview
13
13
years of professional experience
Work History
SR ASSOCIATE QA
AMGEN
Juncos
09.2022 - 06.2024
- Ensured compliance with quality systems, including Trackise, Veeva Vault (CDOCs), MAXIMO, NC, and BTRS, through effective documentation management.
- Process sample inspection, acceptance sampling plan (AQL), and audit mechanical interventions.
- Electronic batch record review (eBR) and SAP transactions audit.
- Actively participate during investigations and root cause evaluations when a discrepancy event is identified.
- Enhanced audit readiness oversight processes by executing Gemba walks to identify potential gaps.
- Supported protocols of validation in the inspection area OQ/PQ, and performed QA role during deviation events.
- Certified in aqueous and viscous solution syringe/vial inspection.
- Maintained responsibility for all inquiries, concerns, and complaints, resolving matters effectively and to the satisfaction of the patients.
ASSOCIATE SCIENTIST
Pall Life Science
Fajardo
03.2020 - 12.2020
- Documented all processes during experiments, keeping meticulous notes of unexpected changes.
- Created and maintained spreadsheets and databases to detail specimen collection and data gathering.
- Utilized specialized software for the simulation and prediction of experimental outcomes.
- Managed laboratory inventory and ensured compliance with safety regulations.
- Executing the validation master plan for filter validation: determination of bacterial viability, filter flush conditions in process fluids, filter compatibility testing, and Product Wet Integrity Testing values.
- Developed processes and techniques to improve the efficiency of laboratory operations.
- Analyzed experimental results and determined whether results fit within standard procedures.
QUALITY CONTROL TECHNICIAN
Pall Life Science
Fajardo
01.2020 - 03.2020
- Provided quality support to ensure that products met quality standards and customer requirements
- Monitored the daily performance of the production team to identify and address issues affecting quality product output.
- Compared samples to standards and specifications by performing detailed measurements and tests.
- Compiled inspection and test data in reports to document compliance with or deviations.
- Audited finished products against applicable industry standards before releasing them for final shipment.
- Lead execution of CAPA, change control processes, and NC resolutions within the batch record team.
- Completed data capture forms, equipment logbooks or inventory forms to support testing procedures.
QUALITY INSPECTOR
Pall Life Science
Fajardo
10.2011 - 12.2019
- Inspected, tested, and measured materials, products, and installations against specifications.
- Documented, filed, and maintained proper inspection records and quality assurance documents.
- Completed evaluations by properly using various gauges, tools, and equipment.
- Executed discrepancy checks by comparing SAP records against MP, enhancing operational clarity.
- Inspected finished products for conformance with established quality standards before release from the facility.
- Reviewed and resolved client concerns and issues, researching relevant details and clearly communicating solutions.
Education
Bachelor of Science - B.A. Science in Biology
Universidad Interamericana De Puerto Rico
Fajardo12.2020
Associate of Science - Associate Degree in Pharmacy Technician
Universidad Interamericana De Puerto Rico
Fajardo06.2013
Certificate - BLS
NUC University
Caguas12-2022
Skills
- Document Control
- Data Analytics
- Regulatory GDP Compliance
- Expertise in Microsoft Systems
- eBR's (MES/PAS system)
- SAP
- LIMS
- MAXIMO
- TRACKISE
- LIMS
Languages
Spanish/English
First Language
Timeline
SR ASSOCIATE QA
AMGEN
09.2022 - 06.2024
ASSOCIATE SCIENTIST
Pall Life Science
03.2020 - 12.2020
QUALITY CONTROL TECHNICIAN
Pall Life Science
01.2020 - 03.2020
QUALITY INSPECTOR
Pall Life Science
10.2011 - 12.2019
Bachelor of Science - B.A. Science in Biology
Universidad Interamericana De Puerto Rico
Associate of Science - Associate Degree in Pharmacy Technician
Universidad Interamericana De Puerto Rico
Certificate - BLS
NUC University
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