Document Control Specialist

Andrea Stone

720-***-**** *************@*****.***

www.linkedin.com/in/andrea-andi-stone

PROFESSIONAL SUMMARY

Over ten years of experience in the pharmaceutical industry with a passion for document control. Skilled in managing electronic and hard copy documentation to support validation and manufacturing operations. Ability to improve processes, contributing to coworker and management satisfaction. Committed to quality and being right the first time.

AREAS OF EXPERTISE

Good Documentation Practices Regulatory Audits Microsoft Word Expert Process Improvements

Compliance with National and International Regulations Author Standard Operating Procedures

Electronic Document Management Document Issuance, Reconciliation and Archival Cross-functional Collaboration Training Program Development

PROFESSIONAL EXPERIENCE

DOCUMENT CONTROL SPECIALIST III, AGC Biologics Longmont, CO May 2023 to Present

Recruited to join the document control team, supporting startup activities for viral vector manufacturing and cell banking operations, while also supporting our sister site in Boulder, processing hard copy and electronic documents.

●Created Microsoft Word styles templates adopted globally at all AGC Biologics locations that drove clear, consistent, and easy to follow documents across the sites

●Developed standard operating procedures, guidelines, and work instructions for document control processes

●Issued, reconciled, and archived controlled documents to support audit readiness

●Formatted documents such as standard operating procedures, master batch records, protocols, etc. supporting ease of use for operators and document accuracy

●Processed document revisions in an electronic document management system, TrackWise Digital

●Acted as the System Administrator for the electronic document management system

●Developed and delivered biweekly training for compliant authorship, review, and approval of documents to reduce metadata related deviations and improve document review cycle time

●Delivered on time corrective and preventative actions (CAPA) and Deviation closure, positively impacting quality metrics

DOCUMENT CONTROL SPECIALIST, Agilent Technologies, INC. Frederick, CO February 2015 to May 2023

Hired to support all pharmaceutical activities involving cGMP documentation, from filing hard copies to processing documents in the electronic document management system. Started out as a document control associate, quickly promoted to document control coordinator, then elevated to document control specialist.

●Drafted and revised standard operating procedures and work instructions for document processing, increasing ease of use for QA and DC staff issuing controlled forms and formatting documents

●Formatted, issued, and tracked electronic and hard copy controlled documents such as master batch records, equipment logbooks, and protocols supporting on-time manufacturing unit operations

●Created multiple standardized MS Word styles templates for company wide use decreasing turnaround times for document revisions

●Provided group and one on one training for the electronic document management system, TMS

●Managed off site archival of controlled documents in compliance with FDA regulation 21 CFR Part 211

●Maintained databases in Access and Excel for controlled form and logbook issuance and reconciliation

●Provided reports to manufacturing, management, and project management about documentation status, supporting the on-time execution of manufacturing process steps

●Generated flow charts for manufacturing drug products and active pharmaceutical ingredients

●Retrieved documentation and subject matter experts for successful FDA, internal, and client audits

●Processed document revisions in an electronic document management system in a timely manner

●Managed projects to ensure on time CAPA closure, supporting site quality metrics

EDUCATION

UNIVERSITY OF NORTHERN COLORADO, Greeley, CO

Bachelor of Arts - 3.72 GPA

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