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Jolie Thomson

@jolieat

Professional of 10+ years supporting regulated environments through meticulous quality system processes, documentation, and data management.

United States

Message

What I'm looking for

I’m seeking remote roles where I can leverage my background in quality systems, documentation, and data management to support reliable, compliant operations. Building on this foundation, I’m interested in opportunities that expand my impact beyond QA, where I can adopt new tools and processes in support of cross-functional teams and evolving business needs.

Detail-oriented Quality Assurance and Document Control professional with 10+ years of experience supporting documentation, data tracking, and process workflows. Proven ability to maintain accurate records, ensure data integrity, and support reporting and operational needs across cross-functional teams.

Experienced in developing and maintaining databases, improving systems and tools, and supporting high-volume documentation and data entry processes. Strong background in document lifecycle management, audit readiness, and compliance within quality systems, with exposure to ISO 13485, FDA 21 CFR 820, and global regulatory standards.

Highly organized, analytical, and systems-driven, with the ability to work independently or collaboratively in remote environments. Adaptable and quick to learn new tools and processes, with a demonstrated ability to apply existing expertise to new workflows, technologies, and team needs.

Experience

Work history, roles, and key accomplishments

Current

Digital Systems & Document Support

Current

Independent

Sep 2021 - Present (4 years 10 months)

Supported independent digital systems and documentation organization projects, including workflow optimization and deliverables tracking. Collaborated remotely with teams and clients on structured documentation and high-detail, self-managed work.

data document attention to detail Digital Systems Support Project Documentation Documentation organization Remote Work Deliverables tracking

Regulatory Affairs Associate

Kinamed Inc.

Oct 2020 - Jun 2021 (8 months)

Managed medical product labeling development, updates, and control to ensure compliance with applicable FDA and quality system requirements. Supported IFUs and packaging documentation updates and document control activities across physical and electronic formats.

Product labeling development FDA 21 CFR Part 820 ISO 13485 labeling layouts content IFUs packaging documentation regulatory reporting GMP Compliance Regulatory Reporting Version Control Change Control Document Control Traceability

Document Control

Kinamed Inc.

Oct 2017 - Oct 2020 (3 years)

Managed end-to-end document control processes, including creation, revision, approval, distribution, and obsolescence, in support of regulatory compliance. Maintained and organized DHF/DMR/DHR files and supported internal and external audits with structured digital and physical filing.

document change control ISO 13485 FDA QSR (21 CFR 820)GMP DHF DMR DHR management inspection instructions (II)audit records routings (RTG)bill of materials (BOM)naming conventions training record management Document Control Version Control SOP Management Traceability Distributed Forms Audit Readiness

Project Assistant

Follmer Development Inc.

Oct 2016 - Jun 2017 (8 months)

Assisted with inventory and digitization of company assets for a new software implementation. Built and maintained asset records and performed data entry/validation into a centralized tracking system.

asset record management centralized tracking system Inventory Digitization Data Validation

Complaint Coordinator & QA Inspector

Kinamed Inc.

Feb 2013 - Feb 2016 (3 years)

Supported product complaint investigations and quality documentation in compliance with regulatory requirements. Managed QA databases and tracking systems, performed incoming inspections, supported CAPA activities, and assisted with audit preparation and verification activities.

Product complaint investigations QA databases data integrity accuracy CAPA audit preparation quality record review shipment QA verification Incoming inspection QA Review Quality Investigations Audit Preparation Tracking Systems

Project Assistant

Kinamed Inc.

Oct 2012 - Jan 2013 (3 months)

Supported and organized physical movement and digitization of product record history. Helped maintain systems to assist with product transfer documentation and organization.

Product record history digitization organization of physical records product transfer support record system maintenance