Zarana Gandhi
Farmington,USA
Summary
Quality Assurance & Regulatory Affairs Specialist | GMP Compliance | DHR Review | Document Control | FDA Labeling Support
Overview
3
3
years of professional experience
1
1
Certification
Work History
Document Coordinator II
Medtronic
Dexter, USA
01.2025 - Current
- Support quality system compliance by coordinating and facilitating cross-functional documentation activities.
- Review and manage documentation to improve record accuracy, completeness, and compliance with internal quality requirements.
- Partner with multiple departments to maintain organized documentation workflows and support regulated operations.
Administrative Assistant / Co-Compliance
ION Pharma USA
Southfield, USA
04.2024 - 01.2025
- Prepared and submitted Structured Product Labeling (SPL) files through CDER Direct for FDA-related regulatory activities.
Maintained electronic filing systems in alignment with document retention and compliance requirements. - Supported internal audits and regulatory documentation requests by providing accurate and timely records.
- Assisted with recruitment support for regulatory-related positions by screening resumes and coordinating hiring activities.
- Developed SOP quizzes and supported onboarding and training activities for new employees.
Document Specialist
FuturePak Pharmaceuticals
Wixom, USA
01.2024 - 04.2024
- Streamlined document control processes to enhance retrieval efficiency and accuracy.
- Coordinated cross-functional communication regarding document updates and revisions.
- Developed training materials for new staff on document management systems and protocols.
- Implemented version control measures to maintain integrity of critical documents.
- Collaborated with quality assurance teams to align documentation with quality standards.
- Assisted in the development of standard operating procedures to improve document handling workflows.
- Managed high volumes of documents efficiently, prioritizing tasks according to deadlines and project requirements.
- Managed file archival and information retrievals.
Quality Assurance Inspector
FuturePak Pharmaceuticals
Wixom, USA
11.2022 - 12.2023
- Support quality system compliance by coordinating and facilitating cross-functional documentation activities.
- Review and manage documentation to improve record accuracy, completeness, and compliance with internal quality requirements.
- Partner with multiple departments to maintain organized documentation workflows and support regulated operations.
Education
Master Of Science - Basic Medical Science
Wayne State University School Of Medicine
Detroit, USA06.2016
Bachelor Of Science - Biological Sciences
Wayne State University
Detroit, USA05.2014
Skills
- QCBD
- SharePoint
- Microsoft Office Suite
- Document Management
- Records Management
- SOP Development
- Compliance Documentation
- Quality Systems
- Training Coordination
- Communication
- Organizational Skills
- Problem Solving
- Team Collaboration
Certification
Regulatory Affairs Expert Program (REAP) from Accreditation Council Medical Affairs (ACMA)
Timeline
Document Coordinator II
Medtronic
01.2025 - Current
Administrative Assistant / Co-Compliance
ION Pharma USA
04.2024 - 01.2025
Document Specialist
FuturePak Pharmaceuticals
01.2024 - 04.2024
Quality Assurance Inspector
FuturePak Pharmaceuticals
11.2022 - 12.2023
Bachelor Of Science - Biological Sciences
Wayne State University
Master Of Science - Basic Medical Science
Wayne State University School Of Medicine