QA Document Control and Training Specialist jobs in United States
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Vera Therapeutics, Inc. · 3 weeks ago

QA Document Control and Training Specialist

positionBrisbane, CA
timeFull-time
remoteOnsite
seniorityEntry, Mid Level
money$90K/yr - $115K/yr
date2+ years exp

Vera Therapeutics is a late clinical-stage biotechnology company focused on developing treatments for serious immunological diseases. The QA Document Control and Training Specialist will oversee the operations of the Document Control and Training systems, ensuring compliance with regulatory requirements and quality standards.

BiotechnologyHealth Care

Responsibilities

Work closely with stakeholders to create, format, and manage controlled documents and templates within the electronic Document Management System (eDMS)
Oversee the entire document lifecycle, including creation, routing, review, approval, periodic review, and archival to maintain data integrity and compliance
Manage document retention program and associated records and ensure proper archiving and retrieval processes are in place
Troubleshoot document issues within Microsoft Suite applications (e.g., Word, Excel) and PDF (e.g., Adobe Acrobat)
Support GxP training initiatives within the organization, acting as a Subject Matter Expert (SME) for training programs
Ensure training content is developed, maintained, and assigned appropriately in the electronic Learning Management System (eLMS)

Qualification

Document Control ManagementGxP Training InitiativesFDA Regulations KnowledgeEDMS AdministrationMicrosoft Word ProficiencyMicrosoft Excel ProficiencyAdobe Acrobat ProficiencyDocumentation PracticesOrganizational SkillsCommunication SkillsProblem-Solving Skills

Required

BA/BS degree in a related field or equivalent experience
2+ years of relevant experience in a regulated environment, preferably within a QA
Strong understanding of FDA, ICH, and international pharmaceutical regulations and guidelines
In-depth understanding of Good Documentation Practices (GDocP) and ALCOA++
Hands-on experience administering eDMS
Advanced Proficiencies in Microsoft Word (formatting, templates, forms, embedded hyperlinks), Microsoft Excel, and Adobe Acrobat are a must
Demonstrated ability to work independently and cross-functionally, building relationships with key stakeholders
Strong organizational skills, attention to detail, and ability to manage multiple priorities in a fast-paced environment
Excellent communication, problem-solving, and issue resolution skills

Preferred

Experience with Veeva is a plus
Experience supporting audits and regulatory inspections with strong knowledge of data integrity and compliance best practices is a plus

Company

Vera Therapeutics, Inc.

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Vera Therapeutics, Inc.
dateFounded in 2016
location
South San Francisco, California, USA
people-size201-500 employees
web-link
https://veratx.com/

Funding

Current Stage
Public Company
Total Funding
$1.23B
Key Investors
Oxford Finance LLCAbingworth
2025-12-09Post Ipo Equity· $261M
2025-06-03Post Ipo Debt· $75M
2024-10-28Post Ipo Equity· $300M

Leadership Team

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David L. Johnson
Chief Operating Officer
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Kerry Cooper
Senior Vice President Medical Affairs
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Recent News

StreetInsider.com
Vera Therapeutics receives FDA priority review for IgA nephropathy drug
2026-01-11
The Motley Fool
Why Vera Therapeutics Stock Zoomed Higher Today
2026-01-08
GlobeNewswire
Vera Therapeutics Announces U.S. FDA Granted Priority Review to Biologics License Application for Atacicept for Treatment of Adults with IgA Nephropathy
2026-01-07
Company data provided by crunchbase