Document Control ǀ Regulatory ǀ Administrative

Summary

Reliable, dedicated, and enthusiastic professional with over 20 years experience in Quality Document Control, Regulatory, and successful collaboration with multiple departments to support projects, and manage paper and electronic file systems for critical business documentation and procedures for several industries.

Skills

Accounting

Adobe Creative Suite

Administrative Operations

Change Management

Clinical Study Start-Up

Document Control/Review

Electronic Health Record (EHR) Applications (Allscripts, athenaPractice, EPIC)

Medical Records and Terminology

Microsoft Access Development

Microsoft Office Suite

Microsoft Windows

Records Management

Regulatory Submission Publishing

Systems Validation

Technical Editing

Training Management

TWIC Card Credential

Professional History

Family Care Network

Bellingham, WA

2022-2023

Medical Records Associate

Responsible for processing the flow of medical record information in a paper based/electronic environment.

Completed requests for release of information for both internal providers and external organizations.

Patient access representative for appointment scheduling.

Sea Mar Community Health Centers

Bellingham, WA

2018-2019

Health Information Management Associate

Responsible for handling and processing the flow of all medical record information in an electronic environment to ensure timeliness, accuracy, and compliance with Health Insurance Portability and Accountability Act (HIPAA).

Led department in volume and accuracy for the indexing and categorization of patient records.

Delivered excellent customer service to patients and external organizations for records requests.

Verified insurance both government (Medicare, Medicaid) and commercial for patients.

Swedish Cancer Institute

Seattle, WA

2016-2017

Regulatory Affairs Coordinator

Regulatory project manager for clinical trial investigative study site activation and maintenance.

Provided excellent customer service and regulatory guidance to patients, study physicians, budgets and contracts, clinical research coordinators, as well as external sponsors and clinical research organizations (CROs).

Proofread and revised sponsor patient Informed Consent Forms (ICFs) with site-specific HIPAA, compensation, and injury language and submitted completed study information to internal and external institutional review boards (IRBs).

Philips Healthcare

Bothell, WA

2015-2016

Document Control and Training Specialist

Systems administrator for managing engineering changes through product lifecycle management (PLM) and enterprise resource planning (ERP) systems for medical device manufacturing.

Managed ECs for device master records (DMR) for traceability, accuracy, and compliance; authored standard operating procedures for Quality System.

Created all manufacturing training courses through training development esystem and developed metric reports for management.

BioRad Laboratories

Woodinville, WA

2015-2015

Document Control Specialist

Responsible for supporting document publishing for clinical diagnostic creation.

Formatted and proofread document for accuracy and adherence to company standards.

Oncothyreon Inc.

Seattle, WA

20092014

Document Control Manager

Manager of document control/change control functions, clinical records, and training,

Project manager and systems validator for conversion of paper document control system to SharePointbased eDMS for SOPs, policies, safety data sheets (SDS), master batch records (MBRs) and technical reports.

Developed MS Access databases for managing and reporting change controls, part number (PN) initiations and revisions, deviations, and corrective and preventative actions (CAPAs).

Created Oncothyreon editorial style guide and templates utilized for submission documents in Common Technical Document (CTD) format used in first successful investigational new drug application (IND) to FDA oncology division.

BioControl Systems

Bellevue, WA

20072009

Document Control Specialist

Responsible for maintaining adherences of BioControl Systems (BCS) product related documentation to ISO requirements for diagnostic testing kits for foodborne pathogens.

Controlled product accuracy by coordinating approval and routing of SOPs and policies.

Performed quarterly quality assurance (QA) audits.

ICOS Corporation

Bothell, WA

20012007

Document Control/Regulatory Associate

Executed regulatory operations function including INDs, annual reports, amendments, and orphan drug applications.

Performed final compilation and publishing of all regulatory submissions to US, Canadian, and European regulatory agencies.

Created and implemented all new templates used for submission of first successful IND in CTD format to FDA oncology division.

Participated in the review of labeling, advertising, and promotional material to ensure compliance with FDA Advertising and Promotional Manual.

Evaluated software from vendors for planned future eCTD submissions for proposal of new publishing system.

Education

Washington State University

Social Sciences

Bellevue Community College

Accounting

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