Work Preference
Summary
Overview
Work History
Education
Skills
Timeline
Generic
Open To Work

LINDSEY ALLEN

Bothell,WA

Work Preference

Job Search Status

Open to work
Desired start date: Open to discussion

Desired Job Title

QA Document Control ManagerQuality Assurance ManagerSenior Quality Assurance ManagerSystem AdministratorDocument Control Manager

Work Type

Full Time

Location Preference

RemoteHybrid
Location: Bothell, WA, USA
Open to relocation: Yes

Salary Range

$155000/yr - $175000/yr

Important To Me

Career advancementWork-life balanceCompany CultureFlexible work hoursPersonal development programsHealthcare benefitsWork from home optionPaid time offPaid sick leave401k matchStock Options / Equity / Profit Sharing

Summary

Detail-oriented QA Document Control Manager with 15+ years of experience in pharmaceutical regulatory compliance and quality management systems. Proven track record in leading document control operations, enhancing inspection readiness, and implementing process optimizations that increased on-time review completion from 57% to 85%. Expertise in managing cross-functional teams and driving digital transformation initiatives, ensuring adherence to FDA and global standards. Committed to fostering a culture of quality and continuous improvement. Authorized to work in the US for any employer.

Overview

18
18
years of professional experience

Work History

QA Document Control Manager

Bristol Myers Squibb
07.2023 - Current
  • Spearheaded document control programs and managed staff in GxP-regulated manufacturing environments.
  • Implemented Records Management Systems (RMS) site-wide, replacing invalidated processes through global collaboration.
  • Developed compliance oversight tools and inspection readiness dashboards to enhance operational efficiency.
  • Championed change control initiatives for QA Document Control.
  • Designed and currently manage the site-wide Periodic Review Board in Veeva EDMS, improving on-time completion from 57% to 85% within the first year as Local Process Owner.
  • Led the Protocol Reduction Program as Process Owner, retiring 141 legacy protocols (68% volume reduction), improving system efficiency and audit readiness.
  • Developed and launched QA SharePoint portal to centralize controlled documentation, SOPs, and resources, enhancing cross-functional access and team efficiency.
  • Served as backup Local Process Owner for the Veeva EDMS Global migration, participating in system mapping, UAT, user training, and audit traceability for 5,000+ documents.
  • Designed and implemented enterprise Key Performance Indicators (KPIs) for document control health, integrated into Quality Council reporting.
  • Built and maintained Smartsheet dashboards to track document routing, EDMS issues, and change control workflow metrics.
  • Led implementation of the Employee Transition Program, ensuring timely document reassignment during terminations, LOAs, and organizational transfers.
  • Provide real-time support and mentorship to QA team members and cross-functional stakeholders during audits, training, and daily operations.
  • Participated in internal and regulatory audits as QA Document Control representative, supporting documentation requests and ensuring inspection readiness.

Senior QA Specialist – Document Control Lead

Bristol Myers Squibb
05.2018 - 07.2023
  • Led the development and implementation of the Controlled Copy issuance process in Veeva Electronic Document Management System (EDMS), a GxP-critical function for traceable form issuance and reconciliation.
  • Partnered with IT and Records Management to design compliant workflows that reduced issuance turnaround time by 80%.
  • Served as site subject matter expert (SME) for Controlled Copy lifecycle, ensuring alignment with 21 CFR Part 11 and audit readiness.
  • Partnered with Global Quality and IT to enhance document governance, metadata structure, and alignment with enterprise standards.
  • Designed and implemented digital workflows that reduced overdue documentation by 30%, strengthening inspection readiness and data accuracy.
  • Led process harmonization initiatives to improve document traceability and ensure consistent practices across multiple product teams.
  • Initiated, revised and approved SOPs, deviations, and CAPA documentation, ensuring compliance with internal and regulatory quality standards (FDA, EMA, ICH).
  • Implemented an electronic document request database, improving visibility and tracking for issued documents.
  • Managed batch record issuance, reconciliation, and review support, ensuring timely and compliant documentation closure.
  • Mentored junior team members and supported audit preparation, fostering a culture of quality ownership and continuous improvement.
  • Primary individual for executing User Acceptance Testing through ValGenesis for system-related enhancements and upgrades.

QA Documentation Specialist

Genentech
04.2012 - 05.2018
  • Supported the digital transformation of site quality systems, improving document retrieval speed and reducing paper record errors.
  • Managed controlled documents and records in DocLink EDMS, maintaining on-time periodic reviews and audit-ready accuracy.
  • Coordinated Change Control records and leadership reviews, ensuring timely evaluations and consistent closure rates.
  • Delivered records management training and implemented secure vault access to strengthen traceability and inspection readiness.
  • Partnered with IT and QA to migrate 5,000+ documents into DocLink EDMS, achieving full adoption across site departments.
  • Prepared audit support packets for internal and regulatory inspections, ensuring rapid access to controlled records.
  • Conducted documentation audits and tracked errors, helping reduce recurring deviations and maintain compliance.

Quality Assurance Documentation Associate

Bio-Rad
12.2011 - 12.2012
  • Supported QA and Document Control functions in a GMP-regulated environment, ensuring accurate formatting, routing, and archival of GMP records per FDA and ISO standards.
  • Participated in change control documentation, deviation tracking, and record retrieval during audits.
  • Streamlined workflows by supporting cross-functional teams, improving document turnaround time and traceability.

Quality Analyst Supervisor

Bericap
01.2009 - 12.2011
  • Supervised QA team members and oversaw inspection protocols for packaging manufacturing.
  • Conducted root cause analysis for nonconformances and implemented corrective actions, improving compliance.
  • Standardized testing documentation to support consistency and audit readiness.
  • Collaborated with manufacturing and engineering to resolve quality issues and strengthen process controls.

Quality Final Inspector

Abbot Vascular
01.2008 - 01.2009
  • Performed final inspections of medical devices to ensure alignment with product specifications.
  • Documented inspection results and worked with QA leads to address deviations.
  • Contributed to continuous improvement initiatives by maintaining detailed inspection records.

Education

General Education (Diploma) -

Julian Charter High School
Temecula, CA
01.2006

Skills

  • Veeva EDMS
  • Document Control & Quality Systems
  • Regulatory Compliance (GxP, FDA, ISO)
  • CAPA, Change Control & SOP Development
  • Process Improvement & Workflow Optimization
  • Risk Management & Auditing Readiness
  • Data Administration & System Integration
  • Root Cause Analysis & Continuous Improvement
  • Cross-Functional Collaboration
  • Training, Onboarding & User Support
  • Project Management
  • Communication, Organization & Attention to Detail

Timeline

QA Document Control Manager

Bristol Myers Squibb
07.2023 - Current

Senior QA Specialist – Document Control Lead

Bristol Myers Squibb
05.2018 - 07.2023

QA Documentation Specialist

Genentech
04.2012 - 05.2018

Quality Assurance Documentation Associate

Bio-Rad
12.2011 - 12.2012

Quality Analyst Supervisor

Bericap
01.2009 - 12.2011

Quality Final Inspector

Abbot Vascular
01.2008 - 01.2009

General Education (Diploma) -

Julian Charter High School

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