SR
Open to opportunities

Sephanie Ramsey

@sephanieramsey

Senior Quality Assurance Specialist with extensive regulatory compliance expertise.

United States
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What I'm looking for

I am looking for a role that challenges my skills in quality assurance and regulatory compliance, within a company that values continuous improvement and innovation.

I am a dedicated Senior Quality Assurance Specialist with over eleven years of experience in the biotech industry, specializing in regulatory compliance and quality management systems. My journey began with a Bachelor of Science in Biology from Rust College, followed by a Master in Arts in Psychology from the University of Arizona. Throughout my career, I have consistently demonstrated my ability to manage complex quality assurance processes and ensure compliance with FDA, DEA, and GMP standards.

In my most recent role at MLM Medical Labs, I manage the controlled document program and oversee scheduling for CLIA inspections, ensuring that our operations meet stringent regulatory requirements. Previously, at HemaCare, I led audit preparations and regulatory inspections, achieving 100% compliance and developing SOPs that significantly improved our quality management practices. My experience also includes conducting internal audits, facilitating training programs, and partnering with cross-functional teams to optimize workflows.

My passion for quality assurance drives me to continuously seek opportunities for improvement and operational efficiency. I thrive in environments that challenge me to uphold the highest standards of quality and compliance, and I am eager to bring my expertise to a forward-thinking organization.

Experience

Work history, roles, and key accomplishments

ML
Current

Sr. Quality Assurance Specialist

MLM Medical Labs

Jan 2025 - Present (6 months)

Managed the controlled document program, tracking and maintaining SOPs and assay procedures. Oversaw scheduling for CLIA inspections, ensuring compliance with regulatory requirements, and maintained, tracked, and revised controlled documentation per GMP & GDP standards. Organized and maintained training records, facility/equipment records, and licensure documentation, ensuring audit readiness by m

HE

Senior Quality Assurance Specialist

HemaCare

Dec 2020 - Dec 2024 (4 years)

Supported Quality Management by reviewing and approving GMP documentation for outsourced activities, ensuring compliance with FDA, DEA, and GMP standards. Led audit preparation and regulatory inspections, developed and implemented SOPs, and conducted internal audits to ensure audit readiness. Led CAPA investigations, tracked actions, provided training, and partnered with teams to optimize distribu

AM

Associate Scientist

AmerisourceBergen

Jul 2018 - Apr 2020 (1 year 9 months)

Developed and monitored quality metrics to ensure compliance across wholesale distribution operations. Assisted in SOP writing and revision, aligning with corporate policies and regulatory expectations. Led audit preparation efforts and provided compliance training to employees, reinforcing quality culture.

CB

Quality Assurance Specialist

Cognate Bioservices

Jul 2014 - May 2018 (3 years 10 months)

Executed document control and change management processes within a GMP environment. Supported regulatory inspections and audits, ensuring adherence to FDA and ISO 13485 standards. Conducted risk assessments and process validations to support operational improvements.

Education

Degrees, certifications, and relevant coursework

University of Arizona logoUA

University of Arizona

Master of Arts, Psychology

0

Focused on advanced psychological theories and research methodologies. Explored various subfields including clinical psychology and cognitive science.

Rust College logoRC

Rust College

Bachelor of Science, Biology

0

Completed coursework covering core biological principles, genetics, and cellular biology. Gained practical experience through laboratory work and scientific inquiry.

Tech stack

Software and tools used professionally

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Sephanie Ramsey - Sr. Quality Assurance Specialist - MLM Medical Labs | Himalayas