Lindsey Allen
Woodinville,WA
Summary
Strategic QA professional with over 12 years of progressive experience in highly regulated environments (FDA, EMA, ICH), demonstrating expertise in Quality Management Systems (QMS), document control governance, inspection readiness, and cross-functional leadership.
Overview
18
18
years of professional experience
Work History
QA Document Control Manager
Bristol Myers Squibb
01.2023 - Current
- Spearheaded document control programs and managed staff in GxP-regulated manufacturing environments.
- Delivered platform upgrades and site-wide training on Veeva EDMS and Records Management System.
- Developed compliance oversight tools and inspection readiness dashboards to enhance operational efficiency.
- Championed change control initiatives as EDMS change agent and backup Local Process Owner.
- Designed Periodic Review Board, increasing on-time PR completion from 57% to 85% within six months.
- Reduced legacy protocol volume by 68% through SOP-driven reassignment and retirement, improving audit readiness.
- Contributed to migration from Junodocs to BMSDocs, ensuring document integrity and seamless user transition.
- Launched centralized QA SharePoint hub for department-wide access to controlled documentation and resources.
Senior QA Specialist – Document Control Lead
Bristol Myers Squibb
01.2018 - 01.2023
- Oversaw batch record issuance and reconciliation, ensuring robust documentation governance across functions.
- Authored deviation reports, SOPs, and change control documents; led CAPAs and root cause analyses.
- Implemented database tools to enhance document request turnaround and tracking efficiency.
- Mentored team members while supporting regulatory inspections and internal audits.
QA Documentation Specialist
Genentech
01.2012 - 01.2018
- Managed SOP lifecycle through DocLink EDMS and supported facility-wide Change Control initiatives.
- Conducted training on records management and ensured secure vault control.
- Contributed to successful rollout of electronic systems across multiple teams.
- Supported document control operations for various GMP manufacturing teams.
QA & Inspection Roles
Various Companies
01.2008 - 01.2012
- Executed quality roles at Abbott, Bericap, and Bio-Rad, acquiring foundational expertise in regulated manufacturing, GMP documentation, and compliance systems.
Education
General Education Diploma - undefined
Julian Charter High School
01.2006
Skills
- Quality assurance expertise
- DMS proficiency
- Inspection readiness and compliance
- Document control methodologies
- Local process ownership for periodic review process
- Change management practices
- Corrective action and analysis
- Key performance indicators development
- Regulatory adherence skills
- Mentorship and team leadership
- Veeva EDMS administration
- Technical support and troubleshooting
- Smartsheet application knowledge
- Quickbase utilization skills
Timeline
QA Document Control Manager
Bristol Myers Squibb
01.2023 - Current
Senior QA Specialist – Document Control Lead
Bristol Myers Squibb
01.2018 - 01.2023
QA Documentation Specialist
Genentech
01.2012 - 01.2018
QA & Inspection Roles
Various Companies
01.2008 - 01.2012
General Education Diploma - undefined
Julian Charter High School
Similar Profiles
Gabriella JordanGabriella Jordan
Sr. Manager, Clinical Data Management at Bristol Myers SquibbSr. Manager, Clinical Data Management at Bristol Myers Squibb
MANISHA MADHURMANISHA MADHUR
Talent Acquisition Specialist at ANSR (Client - Bristol Myers Squibb)Talent Acquisition Specialist at ANSR (Client - Bristol Myers Squibb)
Allison G. HaleAllison G. Hale
Senior Clinical Operations Manager at Bristol-Myers SquibbSenior Clinical Operations Manager at Bristol-Myers Squibb
Makana SteinmetzMakana Steinmetz
Graduate Intern at Bristol Myers Squibb – Upstream Bioprocessing DepartmentGraduate Intern at Bristol Myers Squibb – Upstream Bioprocessing Department
Nathan LimNathan Lim
Valley Electric at Seattle Public SchoolsValley Electric at Seattle Public Schools