Looking for a job

Melissa Suarez

@melissasuarez

I review regulated clinical and pharmaceutical documentation to keep quality, compliance, and batch release operations moving.

United States

Message

What I'm looking for

I'm seeking a remote or North Carolina-based role in quality, operations, customer support, or business coordination where I can support compliance, documentation, workflow improvement, and cross-functional teams.

I'm currently reviewing clinical research data at Thermo Fisher Scientific, verifying accuracy, completeness, and compliance with study protocols, SOPs, and regulatory requirements.

Over nearly 13 years in Thermo Fisher's PSG organization, I supported batch release operations by reviewing batch records, deviations, and investigations for CGMP and FDA compliance. I served as a go-to QA resource, helped prepare for successful regulatory inspections, resolved time-sensitive workflow issues, and supported process improvements that reduced documentation errors.

I also bring healthcare, claims, recruiting, and patient-access experience, along with bilingual English and Spanish communication. I'm looking to bring my quality, operations, documentation, and cross-functional coordination experience to a remote or North Carolina-based team.

Experience

Work history, roles, and key accomplishments

Current

Remote Data Reviewer

Current

Thermo Fisher Scientific

Jun 2026 - Present (3 months)

Perform quality review of clinical research data to ensure accuracy, completeness, and compliance with study protocols, SOPs, and regulatory requirements.

Clinical Research Quality Review Regulatory Compliance Electronic Systems Documentation

Quality Assurance Team Lead / Batch Release Specialist

Thermo Fisher Scientific

Aug 2013 - Jun 2026 (12 years 10 months)

Served as a subject matter expert for QA documentation, compliance requirements, and batch release processes. Reviewed batch records, deviations, and investigations to ensure CGMP and FDA compliance.

GMP FDA Regulations Batch Record Review Audit Readiness Documentation Control Trackwise SAP Workflow Coordination Process Improvement Training Cross Functional Collaboration Issue Resolution

Claims Representative

Crumley Roberts Law

Jan 2011 - Aug 2013 (2 years 7 months)

Managed inbound calls and reviewed legal, medical, and insurance documentation. Provided bilingual English/Spanish interpretation support and coordinated communication across clients, providers, and insurance representatives.

Claims Processing Documentation Review Bilingual Communication Customer Service Coordination

Patient Access Representative

Wake Forest Baptist Hospital

Apr 2007 - Jan 2011 (3 years 9 months)

Registered patients and verified insurance while maintaining HIPAA compliance. Scheduled appointments and managed patient inquiries across multiple specialty clinics.

Patient Registration Insurance Verification HIPAA compliance Appointment Scheduling Bilingual Communication