Namitha Gubbi
Summary
Quality Assurance professional with 6 years of experience ensuring product excellence and customer satisfaction. Adept at enhancing production systems by optimizing metrics and driving continuous improvement. Known for effective project management, collaboration, adaptability, and consistently delivering results in fast-paced environments. Skilled in test planning, execution, and documentation, with focus on maintaining high standards. Outstanding data management and technical writing skills contributing to process improvement and training efficacy.
Overview
13
13
years of professional experience
1
1
Certification
Work History
QA Engineer, Document Control Specialist
BioMerieux
Philadelphia, PA
06.2023 - Current
- Optimized site QMS by developing and implementing Change Management and Corrective Action systems, with metric reporting and data analysis systems
- Created an agile product development system to optimize customer collaboration while resolving gaps in knowledge transfer from R&D to production
- Drove site-wide documentation overhaul and improved record keeping accuracy and GDP at site by 300%
- Managed upgrades to site QMS to facilitate ISO 9001 Certification and spearheaded development of Site Internal Auditor team
- Trained SMEs in Technical Writing principles resulting in 70% decrease of Quality Events from unclear Standard Work Instructions
- Improved document control functionality by migrating over 2000 documents and records to LiveLink Document Control software
- Served as Quality and Regulatory expert in development and production meetings
- Reviewed and optimized test plans for product and process validation in compliance with industry regulations
- Led root cause analysis for product failures, driving corrective actions to prevent recurrence
- Managed and mentored junior engineers and interns on best practices in testing and quality assurance techniques
Engineering R&D Molecular Biologist
Biomeme
Philadelphia, PA
01.2021 - 03.2023
- Fine-tuned sample preparation with engineering and biological techniques to reduce well to well variation across device from 1.5 SD to 0.4 SD
- Optimized nucleic acid extraction from various sample types including nasopharyngeal swabs and blood, increasing device utility by 200%
- Diagnosed and refined error reporting using Python to reduce device error rate from 20% to 5%
- Spearheaded written experiment reports to provide proof of concept for CEO to secure further contracts from DoD
- Independently planned and executed aging studies for medical device risk management
- Initiated Engineering R&D documentation review and developed documentation standards for research team to maintain experimental details and conclusions for auditors
- Collaborated with regulatory department to simplify ISP medical device method of use for CLIA waved status
- Led four audits as per 21 CFR 820 and ISO 13485 regulations, reported non-conformances, conducted Root Cause Analysis, and formulated action plans to resolve findings
- Developed and authored five V&V Test Protocols for ISP medical device design review
- Partnered with team to refine and perfect Integrated Sample Prep (ISP) device – combined 9-well automated nucleic acid sample prep and thermocycling system
R&D Molecular Biologist
Biomeme
Philadelphia, PA
10.2020 - 01.2021
- Collaborated with team to plan and conduct study on efficacy of saliva as Covid19 sample
- Independently authored white paper on saliva sample type efficacy to prevent company investment in an unprofitable product
- Adhered to GLP, GCP, and GMP to work with patient-donated samples and to author SOPs for manufacturing developed product
MS Candidate
Drexel College of Medicine
Philadelphia, PA
08.2018 - 07.2020
- Independently researched role of DNA replication protein, CHTF18, in crossover formation and resolution to expand knowledge on molecular mechanisms of age-related infertility
- Spearheaded new microscopy techniques to increase utility of immunohistochemistry staining to analyze crossover pathway proteins in prophase I spermatocyte spreads in mice
- Thesis: Investigating a Role for CHTF18 in Meiotic Crossover Formation
- Hypothesis: CHTF18 facilitates formation and stability of DNA crossovers to prevent early homolog separation
Ocular Genetics Researcher and Genetics Counselor Assistant
Wills Eye Hospital
Philadelphia, PA
08.2016 - 05.2017
- Developed patient materials and study reports for IRB review and approval
- Collaborated with clinical research coordinators to roll out research protocols, troubleshoot patient screening, treatment, and retention barriers
- Adhered to Good Clinical Practices in all studies and conducted file audits to ensure compliance with GCP
- Conducted quality control on existing data by reviewing CRFs
- Recruited patients using NextGen EMR technology and performed EHR review for patient enrollment across multiple phase 4 clinical trials in adults and pediatrics
- Managed all aspects of patient care including initial referral, scheduling, and coordination of genetic testing
- Demonstrated knowledge of ocular genetic patient care through examination of genetic variants identified in patients and submission of appropriate insurance referrals for testing
Research Assistant
Hochwagen Laboratory
New York, NY
04.2013 - 05.2016
- Invented a mechanism to improve efficiency of Crispr-CAS homologous mutation system in Saccharomyces cerevisiae yeast of SK1 background
- Produced yeast strains for genetic screen to find checkpoint proteins in yeast meiosis
Education
Master of Science - Molecular and Cellular Biology and Genetics
Drexel College of Medicine
Philadelphia, PA01.2020
Bachelor of Arts - Biology
New York University
New York, NY01.2016
Skills
- Technical Writing
- Training Management
- Data Management
- DEI Consultation
- SEO Content Writing
- Product Management
- GLP, GCP, GMP, GDP
- ISO 9001 & 13485
Certification
- ASQ Certified Quality Engineer
- ISO 9001 Internal Auditor
Timeline
QA Engineer, Document Control Specialist
BioMerieux
06.2023 - Current
Engineering R&D Molecular Biologist
Biomeme
01.2021 - 03.2023
R&D Molecular Biologist
Biomeme
10.2020 - 01.2021
MS Candidate
Drexel College of Medicine
08.2018 - 07.2020
Ocular Genetics Researcher and Genetics Counselor Assistant
Wills Eye Hospital
08.2016 - 05.2017
Research Assistant
Hochwagen Laboratory
04.2013 - 05.2016
Bachelor of Arts - Biology
New York University
Master of Science - Molecular and Cellular Biology and Genetics
Drexel College of Medicine