Emily Malave
NH
Summary
Quality and compliance professional with cross-industry experience in regulated manufacturing and clinical research environments. Proven expertise in supporting Quality Management Systems (QMS), audit readiness, CAPA, and regulatory compliance, aligned with FDA, cGMP, GCP, and public health standards. Recognized for translating regulatory requirements into practical, risk-based quality solutions, while partnering cross-functionally to drive continuous improvement, data integrity, and patient and consumer safety.
Overview
5
5
years of professional experience
5
5
Certifications
Work History
Quality Manager
Ardent Mills
Ayer, MA
06.2024 - Current
- Develop, implement, and manage the facility’s comprehensive Quality Management System (QMS) as a strategic framework to ensure product integrity, consumer safety, and alignment with regulatory and public health standards.
- Lead cross-functional quality initiatives, including inspections, audits, and risk assessments, to maintain compliance with food safety and occupational health regulations.
- Direct root cause analyses and implement corrective and preventive action plans that enhance safety outcomes and reduce non-conformance incidents.
- Monitor and evaluate performance metrics to identify trends, mitigate risks, and drive data-informed decisions that strengthen organizational health and efficiency.
- Collaborate with internal teams and external partners to foster a culture of quality, accountability, and continuous improvement while maintaining strong customer relationships.
Quality Technician
Ardent Mills
Ayer, Massachusetts
03.2023 - 06.2024
- Conduct routine quality analyses and equipment calibrations to verify compliance with certification programs, customer specifications, and regulatory standards.
- Ensure product safety and process accuracy by performing detailed testing and validating laboratory results in alignment with QMS and public health protocols.
- Identify and escalate potential food safety risks, exercising authority to halt production or shipments when non-compliances threaten consumer health or regulatory integrity.
- Communicate proactively with customers and logistics partners regarding freight details, scheduling, and product handling requirements to ensure safe and timely delivery.
- Maintain adherence to company policies, food safety regulations, and sanitation standards, supporting a safe production environment and continuous audit readiness.
Patient Service Representative
Quest Diagnostics
Bedford, NH
09.2022 - 02.2023
- Verify patient identification and documentation to ensure data integrity, accurate billing, and compliance with privacy and health information regulations.
- Utilize laboratory information systems and client communication tools to validate and process both written and electronic test orders efficiently and accurately.
- Collect biological specimens including venipuncture, drug screenings, biometric tests, and insurance exams following established clinical and safety protocols.
- Prepare and process specimens through labeling, centrifuging, aliquoting, and secure transport, maintaining strict chain of custody and biosafety standards.
- Support patient care and operational efficiency by ensuring timely specimen handling, accurate data entry, and adherence to corporate and public health guidelines.
Covid-19 Testing Supervisor
RCM Healthcare
Manchester, NH
09.2021 - 06.2022
- Coordinated and maintained sterile testing environments across multiple community and school district locations to ensure accuracy and biosafety in biological specimen collection.
- Administered, interpreted, and processed COVID-19 test results in compliance with CDC and local health department protocols.
- Documented and managed testing data, consent forms, and specimen tracking to support public health reporting and maintain full regulatory compliance.
- Collaborated with school administrators, community leaders, and healthcare staff to coordinate testing logistics and promote safe, effective public health operations.
Education
Master of Science - Organizational Leadership
Southern New Hampshire University
Manchester, NH07-2025
Bachelor of Science - Public Health
Southern New Hampshire University
Manchester, NH04-2023
Skills
- Quality management
- Risk assessment
- Regulatory compliance
- Data analysis
- Continuous improvement
- Process optimization
Certification
Lean Six Sigma Master Black Belt, Management and Strategy Institute, 2025
Research
Tufts Medical Center - Per Diem Clinical Research Coordinator
Support clinical research studies by helping recruit and schedule participants, collecting and organizing study data, and ensuring research activities followed approved protocols and ethical guidelines. Worked closely with research teams to maintain accurate records and support study compliance.
Accomplishments
Study Abroad for Cultural Awareness, Southern New Hampshire University, 2025
Timeline
Quality Manager
Ardent Mills
06.2024 - Current
Quality Technician
Ardent Mills
03.2023 - 06.2024
Patient Service Representative
Quest Diagnostics
09.2022 - 02.2023
Covid-19 Testing Supervisor
RCM Healthcare
09.2021 - 06.2022
Master of Science - Organizational Leadership
Southern New Hampshire University
Bachelor of Science - Public Health
Southern New Hampshire University