MANJIRI NEHE
Regulatory And Quality Assurance Professional
Boston,MA
Summary
Results-driven Quality Assurance Professional in the Biotech Healthcare Industry with expertise in Quality Systems, Compliance, and Training. Adept at leading Quality initiatives, ensuring Regulatory compliance, and driving continuous improvement. Passionate about optimizing Quality management processes to enhance operational efficiency.
Overview
5
5
years of professional experience
6
6
years of post-secondary education
Work History
Quality Assurance Associate II
Akston Biosciences
02.2023 - Current
- Led the implementation of the eQMS MasterControl Training and Document Management Module, ensuring seamless transition from paper-based training compliance.
- Led the onboarding process for new employees in eQMS, assigned training, and resolved non-compliance issues in the training program.
- Authored and managed SOPs and work instructions workflows for the Document Management Module.
- Conducted classroom training for new hires on eQMS, developed courses and exams to enhance training effectiveness.
- Maintained and optimized eQMS functionality, troubleshooting user issues in collaboration with the technical team and providing user training.
- Established and developed a QA review system for audit trails in GMP-related software, ensuring 21 CFR Part 11 compliance.
- Provided on-floor QA representation during internal and external audits, supporting equipment validation data review.
- Provided QA support for GMP manufacturing operations, ensuring compliance and assisting with deviations, change controls, and CAPAs to drive timely resolutions.
- Performed QA review of QC analytical records, analytical Excel templates, assay validation data, stability study data, EM reports, and manufacturing production batch records.
- Reviewed GMP documents, including warehouse and material records, equipment logs, and employee lab notebooks to maintain regulatory standards.
- Served as a core Quality Team member, coordinating extensively with Manufacturing, Process Development, and Quality Control to ensure training and GMP data review compliance.
Regulatory Affairs Project Intern
Synthera Health
09.2022 - 12.2022
- Collaborated with an industry sponsor to develop a comprehensive regulatory strategy for medical devices and digital diagnostics products, ensuring compliance across all phases of the product lifecycle.
- Assessed product modifications for regulatory impact, ensuring timely updates to market registrations and maintaining compliance with global regulatory requirements.
- Designed and executed Regulatory 510(k) and De Novo submission pathways, formulating effective marketing strategies and reimbursement methodologies to support product commercialization.
- Conducted in-depth market research on predicate devices, gaining valuable real-time experience with cutting-edge innovations in the medical device sector.
Senior Intern Quality Assurance Systems
Thermo Fisher Scientific Inc.
01.2022 - 07.2022
- Enhanced proficiency in FDA and EU regulations, ensuring compliance with required statements for the site's manufactured products.
- Developed a deep understanding of Quality Management Systems while operating in a GMP/GLP-regulated environment.
- Conducted comprehensive gap analyses, authored and revised Standard Operating Procedures (SOPs), and generated key quality metrics to support compliance initiatives.
- Assessed system maturity and led the implementation of continuous improvement initiatives to enhance overall quality effectiveness.
- Played a key role in aligning the Quality Management System with ISO 13485 and FDA standards by supporting ongoing compliance efforts.
- Generated and maintained quality metrics dashboards, ensuring accurate tracking and reporting of key performance indicators (KPIs) for QMS compliance.
- Partnered with cross-functional teams in production and quality to strengthen and maintain a robust quality management system.
- Oversaw the maintenance and enhancement of quality system effectiveness, gaining hands-on experience in Viral Vector Manufacturing processes.
Regulatory Affairs Project Intern
Montalvo Corporation
09.2021 - 12.2021
- Contributed to the Experimental (XN) project by collaborating with an industry sponsor to deliver project requirements effectively.
- Conducted extensive market research to support the sponsor in identifying applications of 3D printing in the medical device industry.
- Performed regulatory analysis to aid in the development of quality systems for medical device products, ensuring alignment with CAPA and quality monitoring requirements.
Clinical Document Specialist
TransPerfect Solutions
12.2019 - 02.2021
- Conducted Clinical Document Quality Checks using the Electronic Trial Master File (eTMF), ensuring compliance with regulatory requirements.
- Designed and implemented a strategy for team-wide Quality Assurance and Compliance Checks for documentation, improving adherence to regulatory standards.
- Assessed weekly team Quality and Productivity metrics, prepared performance evaluations, and developed structured training agendas.
- Led and delivered Team-Training Presentations to enhance document compliance knowledge and best practices.
- Successfully assessed Safety Documents by performing 7-Point Quality Checks to maintain accuracy and consistency.
- Developed a strong working understanding of Clinical Trial Documentation, Quality Management Systems, and Clinical Research Studies
Summer Quality Intern
Glenmark Pharmaceuticals
- Hands-on experience in drug manufacturing (GMP) and clinical/ laboratory practices
- Assisted the clinical project teams to ensure consistency in the assessment and recording of Quality events
- Gained an excellent understanding of the Pharmaceutical Industry processes and material workflow and establish drug safety and efficacy profile for Regulatory/ FDA Compliance
Education
Master of Science - Regulatory Affairs
Northeastern University
Boston 04.2021 - 12.2022
Bachelor of Science - Pharmacy
University of Pune
India 07.2015 - 06.2019
Skills
USFDA Compliance Expertise
Timeline
Quality Assurance Associate II
Akston Biosciences
02.2023 - Current
Regulatory Affairs Project Intern
Synthera Health
09.2022 - 12.2022
Senior Intern Quality Assurance Systems
Thermo Fisher Scientific Inc.
01.2022 - 07.2022
Regulatory Affairs Project Intern
Montalvo Corporation
09.2021 - 12.2021
Master of Science - Regulatory Affairs
Northeastern University
04.2021 - 12.2022
Clinical Document Specialist
TransPerfect Solutions
12.2019 - 02.2021
Bachelor of Science - Pharmacy
University of Pune
07.2015 - 06.2019
Summer Quality Intern
Glenmark Pharmaceuticals
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