Indira Euceda
Medical Device & Pharmaceutical Lab Analyst
South Brunswick Township,NJ
Summary
Detail-oriented laboratory professional with hands-on experience in pharmaceutical microbiology, analytical testing, and medical device validation. Proficient in sterility and bioburden testing, test method validation, and ensuring compliance with GMP, GxP, and FDA regulations. Demonstrated ability to support quality control initiatives, improve lab protocols, and consistently deliver accurate, audit-ready data in regulated environments. Eager to contribute to quality assurance and product safety within the pharmaceutical, biotechnology, or medical device industries.
Overview
4
4
years of professional experience
Work History
Medical Device Lab Analyst
Kymanox
12.2023 - Current
- Perform design verification testing using qualified instruments to perform functional testing of pharmaceuticals, medical devices, and combination products to support customer design and development activities. Examples of testing include: Delivered Volume, Leak testing, Break-loose/Glide Force testing, Container Closure Integrity (CCI) testing, and Gage R&R studies.
- Perform test method validation testing to ensure that testing procedures are accurate, reliable, and suitable for their intended purposes, meeting regulatory requirements and customer specifications.
- Adhere to company protocols, safety regulations, and industry standards (e.g., FDA, ISO 13485) when conducting tests, handling materials, and using equipment.
- Perform mechanical testing using the Instron testing machine to assess the strength, durability, and flexibility of medical device components.
- Use Keyence vision systems to perform detailed inspections of medical device components. This includes checking for defects, measuring micro-structures, surface roughness, and verifying dimensions of small or complex parts that cannot be easily measured with traditional tools.
- Actively participate in the Safety Committee, collaborating with team members to review and improve workplace safety practices, conduct risk assessments, and recommend safety enhancements.
- Train junior team members on testing procedures, equipment usage, and safety protocols, contributing to skill development and team efficiency.
- Manage and track test samples throughout the testing process, ensuring proper labeling, storage, and handling of all samples to maintain sample integrity and comply with regulatory standards.
- Write deviation reports, investigating non-conformances, identifying root causes, and implementing corrective and preventive actions (CAPA) to resolve issues and prevent recurrence, ensuring compliance with regulatory standards and company protocols.
Medical Devices and Combination Products Analyst
Contracted to Pfizer
08.2024 - 12.2024
- Employed by Kymanox as a contractor supporting Pfizer’s Medical Devices and Combination Products (MDCP) Lab
- Performed routine quality control and validation testing on medical devices (e.g., delivered volume, leak testing, plunger movement), ensuring compliance with FDA regulations and Pfizer's internal standards.
- Conducted detailed analysis of test data, documented results through ELN (Electronic Lab Notebook).
- Collaborated closely with engineers in revising and updating Standard Operating Procedures (SOPs) and test methods to enhance testing protocols and improve lab efficiency.
Laboratory Prep Assistant
Rowan University
09.2022 - 05.2023
- Prepared and standardized samples, reagents, media, and solutions required for academic experiments, ensuring accuracy and consistency.
- Assisted in the maintenance and calibration of laboratory equipment, including cleaning and sterilizing glassware, troubleshooting issues, and ensuring optimal performance of instruments.
- Managed laboratory inventory, restocked supplies, and proactively reported low stock levels to supervisors for timely reordering.
- Maintained detailed and accurate records of tasks performed during each shift, ensuring proper documentation for future reference.
- Set up experiment stations, organized equipment, and labeled materials and solutions to create a safe, efficient, and organized environment for student experiments.
- Provided hands-on assistance to students during lab sessions, offering guidance on experimental procedures, safety protocols, and troubleshooting technical issues.
- Communicated effectively with supervisors, students, instructors, and faculty to coordinate lab activities, report problems, and share critical information.
- Ensured proper disposal of biohazardous and chemical waste in accordance with safety and regulatory standards.
- Monitored expiration dates of lab supplies, chemicals, media, and solutions to ensure all materials were current and safe for use.
- Occasionally cared for live organisms, ensuring their well-being and proper maintenance of their environments.
QC Microbiology / QC Analytical Lab Intern
Renaissance Lakewood, LLC
05.2022 - 08.2022
- Collaborated with QC Scientists in both of the Microbiology and Analytical Spray Lab departments to gain hands-on experience in quality control processes and testing.
- Adhered to GMP and FDA guidelines, ensuring compliance with company safety policies and controlled substance handling procedures.
- Performed Microbiological Quality Control testing on media, reagents, and identification materials, including Growth Promotion, Membrane Filtration Method, Microbial Limit Test, Water Analysis, and Endotoxin Testing.
- Assisted in the preparation of culture media, ensuring proper sterilization and autoclaving of equipment and supplies to support microbial growth and testing.
- Conducted microbial identification using both manual testing methods and automated systems to accurately identify microorganisms.
- Managed lab stock cultures, performing dilutions as required by procedure, protocol, or US Pharmacopeia guidelines for evaluative testing.
- Maintained and calibrated laboratory equipment, ensuring all instruments were properly functioning and met required specifications.
- Utilized quality systems (e.g., LIMS, VIOTA, VITEK, SprayVIEW Measurement Systems) for data tracking, test management, and reporting.
- Performed CDMO testing and validation for unit-dose, bi-dose, and multi-dose nasal sprays, including Spray Pattern, Plume Geometry, Particle Size Distribution, Actuation Parameters, and device functionality testing.
- Tested chemical components and products as assigned, utilizing a variety of laboratory instruments and equipment, including analytical balances, pH meters, viscometers, densitometers, and performing wet chemical analysis, while ensuring proper maintenance of all instruments.
- Updated lab notebooks following Good Documentation Practice (GDP) standards, ensuring accurate and complete records, which were reviewed and approved by a mentor to maintain compliance with GDP guidelines.
Undergraduate Research Assistant
Rowan University
09.2021 - 05.2022
- Supported faculty researchers, assisting with experiment design and implementation.
- Developed skills in various research methodologies, ensuring high-quality work across diverse projects.
- Cultured and maintained adipose-derived stem cells (ADSCs) under sterile conditions, following strict aseptic technique and biosafety protocols.
- Performed routine passaging, seeding, and cryopreservation of ADSCs in 2D culture.
- Assisted in experiments involving differentiation of stem cells into adipogenic, osteogenic, and chondrogenic lineages.
- Prepared and analyzed samples using microscopy (e.g., phase-contrast), cell viability assays (e.g., Trypan Blue, MTT), and staining protocols (e.g., Oil Red O, Alizarin Red).
- Maintained accurate lab notebooks and assisted with data collection and statistical analysis using [e.g., SciCord, Excel, ImageJ].
- Presented research findings at university events, showcasing the value of undergraduate research efforts.
Education
B.S. - Biological & Biomedical Sciences
Rowan University
Glassboro, NJAssociate of Science - Liberal Arts & Sciences
Middlesex College
Edison, NJ 05.2001 -
Skills
- Aseptic technique & sterile sample handling
- Sterility and bioburden testing expertise
- Medical device test method validation & design verification testing
- GMP, GxP compliance and FDA standards
- Microbial testing & environmental monitoring
- Support for internal audits & regulatory inspections
- Cell culture & stem cell maintenance
- Analytical testing: pH, HPLC, UV-Vis, titration
- ELN & LIMS documentation
- Deviation writing & root cause analysis
- SOP revision & compliance support
- Data integrity & audit readiness
Timeline
Medical Devices and Combination Products Analyst
Contracted to Pfizer
08.2024 - 12.2024
Medical Device Lab Analyst
Kymanox
12.2023 - Current
Laboratory Prep Assistant
Rowan University
09.2022 - 05.2023
QC Microbiology / QC Analytical Lab Intern
Renaissance Lakewood, LLC
05.2022 - 08.2022
Undergraduate Research Assistant
Rowan University
09.2021 - 05.2022
Associate of Science - Liberal Arts & Sciences
Middlesex College
05.2001 -
B.S. - Biological & Biomedical Sciences
Rowan University
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