Open To Work
Sindhu Yellanagari
Sacramento,CA
Summary
Detail-oriented Regulatory Affairs and Quality Assurance professional with a graduate degree in Regulatory Affairs. Adept at interpreting FDA and ICH guidelines, managing GMP, GDP and ISO-compliant documentation, and coordinating with cross-functional teams to streamline submission workflows. Skilled in regulatory writing, batch record review, and inspection readiness. Committed to continuous learning and regulatory excellence, with hands-on training in pharmaceutical quality systems and clinical documentation.
Offering detail-focused approach and readiness to learn and develop in quality-focused environment. Brings understanding of quality control principles and basic knowledge of inspection techniques. Ready to use and develop analytical skills and attention to detail.
Strong focus on team collaboration and achieving impactful results. Dependable and flexible, adept at identifying defects, implementing corrective actions, and maintaining compliance with industry standards. Known for precision in executing test plans, excellent problem-solving skills, and strong communication with cross-functional teams.
Overview
3
3
years of professional experience
1
1
Certification
Work History
Quality Assurance Technician
Orca Bio
California
09.2025 - Current
- Performed real-time batch record, logbook, and QC documentation review to ensure strict cGMP and GDP compliance.
- Provided on-the-floor QA support, troubleshooting manufacturing issues to minimize downtime and maintain production flow.
- Conducted routine GMP walk-throughs to verify operational readiness and promptly escalated quality risks.
- Supported quality systems including deviations, CAPA, and document control to strengthen data integrity and batch disposition.
- Conducted routine quality inspections to ensure compliance with industry standards and regulatory requirements.
- Collaborated with cross-functional teams to resolve quality-related issues and improve product reliability.
- Conducted root cause analyses for identified defects, implementing preventive measures to minimize recurrence rates.
- Performed thorough inspections of incoming materials and outgoing products.
Quality Control Technician
Hendler Family Brewing
Massachusetts
11.2024 - 09.2025
- Coordinated regulatory documentation and internal audits supporting GMP readiness and product traceability.
- Contributed to the development and review of regulatory submissions, including internal quality reports and supporting documentation for filing.
- Streamlined CAPA tracking workflows and participated in root cause investigations for packaging and process deviations.
- Performed quality inspections across production batches, ensuring alignment with FDA standards and internal specifications.
- Delivered SOP-based training sessions for new staff, reinforcing best practices and regulatory compliance.
Quality Assurance Intern
CuriRx
Wilmington, MA
01.2024 - 04.2024
- Conducted ISO 9001 gap assessment and recommended updates to SOPs and QMS documentation, improving audit preparedness.
- Authored a site-wide Quality Manual and participated in creating IND and NDA supporting materials, including master files and technical SOPs.
- Reviewed batch manufacturing records and ensured full compliance with ICH/FDA documentation requirements.
Research Lab Assistant Co-op
CuriRx
Wilmington, MA
01.2023 - 07.2023
- Documented experimental procedures and results in accordance with Good Laboratory Practices (GLP).
- Ensured timely completion of projects by prioritizing tasks and managing deadlines effectively.
- Operated and calibrated analytical instruments for product characterization, ensuring traceable and inspection-ready data.
- Assisted the QA team with document control, deviation logging, and sample tracking systems.
Education
Master of Science - Regulatory Affairs
Northeastern University
Boston, USA05.2024
Bachelor's - Pharmacy
VIPER
Hyderabad, India06.2021
Skills
- Frameworks & Regulations: FDA Regulations, ICH Guidelines, ISO 9001/13485, GCP, GLP, cGMP, QMS, Audit Preparation
- Documentation & Systems: Master Control, Informed Consent Forms (ICFs), Investigator Brochures, Regulatory SOPs, Batch Records, Document Control Systems
- Tools and Technologies: HPLC, Nanodrop, pH Meter, Solo-VPE, Orbisphere 3000, Anton Paar QC Tools, SDS-PAGE, MDSC, Microsoft Office Suite
Certification
- Drug Commercialization- Coursera
- Drug Discovery- Coursera
Work Availability
monday
tuesday
wednesday
thursday
friday
saturday
sunday
morning
afternoon
evening
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Accomplishments
- Used Microsoft Excel to develop inventory tracking spreadsheets.
Work Preference
Job Search Status
Open to workWork Type
Full TimeLocation Preference
RemoteOn-SiteSalary Range
$3/hr - $33/hrTimeline
Quality Assurance Technician
Orca Bio
09.2025 - Current
Quality Control Technician
Hendler Family Brewing
11.2024 - 09.2025
Quality Assurance Intern
CuriRx
01.2024 - 04.2024
Research Lab Assistant Co-op
CuriRx
01.2023 - 07.2023
Bachelor's - Pharmacy
VIPER
Master of Science - Regulatory Affairs
Northeastern University