Amala Viswanath
Bothell,WA
Summary
Results-driven Quality Assurance and CMC professional with progressive experience supporting GMP-compliant sterile manufacturing, biologics and small molecule drug product operations, and cross-functional product lifecycle activities in highly regulated environments. Proven expertise in aseptic compounding, filling, batch disposition, change control, CAPA, deviations, batch record review, contamination control strategy, disinfectant efficacy studies, cleaning validation support, process validation, PPQ readiness, and inspection readiness. Experienced partnering with Manufacturing, Quality Control, Engineering, Supply Chain, and Technical Operations teams to ensure manufacturing continuity, operational excellence, and regulatory compliance. Strong background in risk assessment, root cause analysis, technical documentation, continuous improvement, and quality systems optimization. Positioned to contribute to CMC, QA, and manufacturing leadership roles supporting late-stage development, commercialization, and compliant product supply
Overview
5
5
years of professional experience
1
1
Certification
Work History
Senior Quality Assurance Specialist
Just – Evotec Biologics
01.2025 - Current
- Support GMP manufacturing operations and lifecycle activities for biologics products in commercial and development environments.
- Support process validation activities, PPQ readiness, documentation readiness, and manufacturing compliance.
- Support contamination control programs, environmental monitoring compliance, and cleaning validation readiness.
- Lead internal audit activities and support external audit preparation
- Lead inspection readiness, PLI readiness, gap assessments, and quality system improvement initiatives.
- Review and approve deviations, CAPA, change controls, and risk assessments within electronic quality systems.
- Partner cross-functionally with Manufacturing, QC, Supply Chain, Engineering, and Technical Operations to resolve quality and process issues.
- Analyze quality metrics and trends to identify risks and drive continuous improvement actions.
- Train personnel on GMP systems, investigations, CAPA processes, and compliance expectations.
- Drive SOP revisions, workflow enhancements, and operational excellence initiatives
- Serve as SME during internal, client, and regulatory inspections, supporting audit hosting and response coordination
Quality Assurance Specialist
Just – Evotec Biologics
05.2023 - 12.2024
- Supported QMS operations, audit activities, and quality event management in a regulated biologics environment.
- Reviewed and assessed quality events (deviations, CAPA, change control, complaints, risk assessments) for compliance
- Managed CAPA lifecycle, ensuring timely closure and effectiveness
- Performed trend analysis and risk assessments to identify compliance gaps and improvement opportunities that informed quality strategies
- Supported internal and external audits, including documentation preparation and SME participation
- Developed and delivered training on QMS processes and system updates to enhance team proficiency and ensure adherence to regulatory standards
- Partnered with Manufacturing to ensure compliance and support investigations
- Designed ComplianceQuest dashboards to improve visibility of quality metrics and support audit readiness efforts
- Participated in continuous improvement initiatives, including SOP updates and process optimization
Senior Quality Scientist / Microbiologist
United Health Group
01.2021 - 06.2021
- Supported sterile manufacturing operations for biologic drug products, including aseptic compounding, filling, and batch disposition activities in GMP-regulated environments.
- Provided quality oversight for fill/finish operations, ensuring adherence to aseptic processing requirements, line clearance, gowning practices, and controlled environment procedures.
- Reviewed batch production records, in-process documentation, and testing results to support timely product disposition and release readiness decisions.
- Partnered with Manufacturing, Quality Control, and Operations teams to resolve deviations, documentation issues, and production events impacting filling operations.
- Developed and executed disinfectant efficacy studies to qualify sanitization agents and strengthen contamination control strategy for sterile manufacturing areas.
- Supported environmental monitoring programs, microbiological trending, and investigations of excursions to maintain compliant cleanroom operations.
- Led deviation investigations and CAPA implementation using root cause analysis methodologies to improve sterile manufacturing reliability.
- Authored and revised SOPs related to aseptic processing, cleaning and disinfection, batch documentation, and GMP compliance.
- Supported internal, client, and regulatory audit readiness for sterile manufacturing and fill/finish operations.
Education
Master of Science - Microbiology
Mahatma Gandhi University
Bachelor of Science - Microbiology
Amrita Viswa Vidyapeetham
Skills
GMP/CMC Regulatory Compliance Sterile Manufacturing Operations Aseptic Compounding & Filling Batch Disposition / Release Readiness Biologics Drug Product Manufacturing Small Molecule Drug Product Support Change Control Management CAPA Management Deviation Investigations Batch Record Review Contamination Control Strategy Disinfectant Efficacy Studies Cleaning Validation Support Process Validation Support PPQ Readiness Inspection Readiness / PLI Readiness Internal & External Audit Support SOP Development / Documentation Control Risk Assessment Root Cause Analysis Process Improvement / Continuous Improvement Cross-Functional Collaboration Stakeholder Management Project Coordination Regulatory Compliance (FDA / EU) Veeva / eQMS Systems Microsoft Excel
Accomplishments
- Deviation Backlog Reduction: Led a quality improvement initiative reducing non-conformance backlog by 97% within 6 months through structured triaging, effective prioritization and CAPA effectiveness.
- Real-Time QA Impact: Reduced batch record errors by performing real-time QA oversight on the shop floor ensuring right-first-time documentation.
- Inspection Readiness & Audit Support: Served as Subject Matter Expert (SME) during internal, client, and regulatory audits, ensuring documentation readiness and compliance with regulatory expectations.
- Efficient QMS Development: Minimized deviations and compliance risks by revamping change control processes and improving workflow efficiency.
- SOP Authoring & Investigation Optimization: Enhanced investigation processes and audit readiness by improving templates and authoring SOPs aligned with regulatory standards.
- Quality System Improvements: Accelerated batch release timelines and reduced review bottlenecks, improving operational efficiency and compliance outcomes.
- Real-Time Compliance Dashboards: Designed ComplianceQuest dashboards to track NC/CAPA trends, improving visibility and inspection readiness.
- Process Efficiency & Risk Trending: Developed metrics for batch review and quality events, enabling proactive identification of compliance risks and trends.
- Deviation & CAPA Standardization: Standardized deviation and CAPA workflows, improving consistency, efficiency, and closure timelines.
- Cross-Functional Team Leadership: Led cross-functional initiatives to align quality processes, improve communication, and meet compliance objectives.
- Effective Deviation Handling: Managed high-volume deviation triaging and closure, ensuring compliance with timelines and regulatory standards.
- Harmonized Quality Processes: Implemented structured approaches to deviation classification and risk prioritization, improving resolution timelines.
Professional Development
- Master of Science in Microbiology, Mahatma Gandhi University
- Bachelor of Science in Microbiology, Amrita Viswa Vidyapeetham
- Quality Assurance & Control Certification, University of California San Diego
- Certified Quality Improvement Associate, America Society for Quality (ASQ)
- Visual Inspection Workshop, The Parenteral Drug Association (PDA)
- Environmental Monitoring Course, Food & Drug Association (FDA)
- Sterile Compounding Facility Course, Food & Drug Association (FDA)
Certification
- Certified Quality Improvement Associate (CQIA)
American Society for Quality - QA and QC for Drugs and Biologics - UC San Diego
Timeline
Senior Quality Assurance Specialist
Just – Evotec Biologics
01.2025 - Current
Quality Assurance Specialist
Just – Evotec Biologics
05.2023 - 12.2024
Senior Quality Scientist / Microbiologist
United Health Group
01.2021 - 06.2021
Master of Science - Microbiology
Mahatma Gandhi University
Bachelor of Science - Microbiology
Amrita Viswa Vidyapeetham