Open to opportunities

Pamela Scott

@pamelascott

Message

Experienced quality assurance professional specializing in medical device documentation.

United States

Message

What I'm looking for

I seek a QA or technical writing role in medical device or clinical lab environments where I can strengthen QMS documentation, support audits, train staff, and improve compliance processes in a collaborative, process-oriented team.

I am a quality assurance professional with extensive experience supporting medical device and clinical laboratory operations, specializing in SOP editing, document control, and cGMP/QMS compliance. I edit, revise and update manufacturing instructions and SOPs to align with SME and GMP guidelines and facility QMS requirements.

I have served as a document control backup, managed employee training compliance, performed batch record and DMR reviews, and supported audits and labeling/document retention activities. My laboratory background includes QC assay execution, equipment calibration/maintenance oversight, inventory management, and hands-on research and lab management experience.

Experience

Work history, roles, and key accomplishments

Sr Quality Assurance Associate

Sekisui Diagnostics

May 2019 - Mar 2023 (3 years 10 months)

Edited and managed controlled manufacturing documents and SOPs per SME and cGMP, submitting change controls and performing batch record review to release lots. Managed training compliance, equipment calibration logs, and supported electronic SOP and labeling revisions.

Document Control SOPs Change Control Batch Record Review Equipment Calibration

Quality Assurance Technician

Children's Hospital of Philadelphia

Oct 2014 - Apr 2016 (1 year 6 months)

Reviewed and revised SOPs, managed change controls and deviations, and reviewed QC release assays and Certificates of Analysis to ensure cGMP compliance. Supported audits, managed document control and training records, and handled biological material inventory and release.

Change Control Document Control Batch Record Review Audit Support Inventory Management

Senior Research Technician

Children's Hospital of Philadelphia

Sep 2013 - Oct 2014 (1 year 1 month)

Conducted microbiological QC testing (bioburden, endotoxin, ELISA, Western Blot, pH/osmolality) and evaluated preliminary results to support product release. Participated in test method development, SOP revisions, equipment maintenance, and inventory control to maintain cGMP-compliant QC operations.

Western Blot Method Development

Laboratory Researcher II

Rutgers University

Jul 2004 - Jul 2012 (8 years)

Managed day-to-day lab operations including ordering supplies, equipment maintenance, staff training, and protocol coordination for animal research. Performed molecular biology assays, small-animal surgeries, immunohistochemistry, and data preparation to support research programs.

Laboratory management Animal Handling Small Animal Surgery Protocol Preparation