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Hemant Patel

@hemantpatel2

Quality assurance specialist at Thermo Fisher Scientific; supported PAS-X eMBRs for Merck vaccine manufacturing.

At Thermo Fisher Scientific, I reviewed batch records, reconciled materials, and maintained quality records and product specifications in LIMS for regulated pharmaceutical products.

At Merck & Co., I used PAS-X daily to execute electronic batch records for MMR vaccine manufacturing. I also helped design, review, and test eMBRs, gathered workflow requirements, and supported users on the manufacturing floor.

Across pharmaceutical, vaccine, and biologics manufacturing, I’ve supported deviation investigations, CAPA, change control, and inspection readiness. I hold an M.S. in Regulatory Affairs & Quality Assurance and am an ASQ Certified Quality Auditor.

Experience

Work history, roles, and key accomplishments

Quality Assurance Associate

Thermo Fisher Scientific

May 2023 - Aug 2026 (3 years 3 months)

Performed batch record reviews, material reconciliations, and record verification to ensure accurate, compliant processing of regulated pharmaceutical products. Reviewed and maintained product specifications, quality records, certificates of analysis, and GMP documentation in LIMS.

Batch Record Review LIMS GMP GLP ISO SOPs Data Management Audit Readiness

Quality Assurance Specialist

B. Braun Medical Inc.

Oct 2022 - May 2023 (7 months)

Participated in deviation investigations and corrective actions (CAPA) supporting compliant FDA-regulated operations. Evaluated change controls, specifications, and records to ensure alignment with internal procedures and regulatory commitments.

Deviations and Investigations CAPA Change Control FDA Regulations GMP Inspection Readiness

Quality Assurance Specialist

Acme-Hardesty Company

Jan 2022 - Oct 2022 (9 months)

Ensured supplier qualification and raw material handling complied with government regulations and internal specifications, supporting supply chain continuity. Coordinated raw material delivery schedules and managed certificates of analysis and documentation review.

Supplier Qualification Raw Material Handling Supply Chain Documentation Review Quality Management Systems

Analyst III, Quality Assurance

McNeil Consumer Healthcare

Jun 2021 - Jan 2022 (7 months)

Evaluated microbiological trends, contamination risks, and quality events while supporting CAPA activities. Supported QA testing and technical support for OTC healthcare products while ensuring GDP compliance and data integrity.

Microbiology CAPA GDP Data Integrity Environmental Monitoring Contamination Control

Quality Assurance Specialist

Bristol Myers Squibb

Oct 2020 - Jun 2021 (8 months)

Supported CAPA development and remediation projects for inspection readiness, applying project management to track actions to closure. Conducted cGMP batch record audits for sterile biologics manufacturing operations.

CAPA Project Management GMP Batch Record Review Sterile Biologics Root Cause Analysis

Biotechnician – MMR II Viral Manufacturing Technician

Merck & Co.

Apr 2012 - Oct 2020 (8 years 6 months)

Performed GMP-compliant testing and documentation supporting MMR vaccine production of ~10 million doses per year. Used PAS-X MES daily to execute cGMP vaccine manufacturing and helped design, review, and test electronic Master Batch Records.

PAS X MES EMBR GMP Vaccine Manufacturing Aseptic Processing LIMS Deviations and Investigations CAPA Inspection Readiness Potency Testing Sterility Testing Viral Titer Testing

Formulation Associate

Johnson & Johnson

Jan 2008 - Apr 2012 (4 years 3 months)

Led formulation and prototype development for consumer healthcare products, partnering with R&D, Regulatory Affairs, Marketing, and Manufacturing. Supported technical development of new products by translating business requirements into formulation specifications.

Formulation Development Prototype Development Requirements Gathering Cross Functional Collaboration Regulatory Affairs