QA Document Control and Training Specialist

Vera Therapeutics, Inc. • Brisbane, CA

15h • $90,000 - $115,000

About The Position

Vera Therapeutics (Nasdaq: VERA), is a late clinical-stage biotechnology company focused on developing treatments for serious immunological diseases. Vera’s mission is to advance treatments that target the source of immunologic diseases in order to change the standard of care for patients. Vera’s lead product candidate is atacicept, a fusion protein self-administered at home as a subcutaneous once weekly injection that blocks both B-cell Activating Factor (BAFF) and A Proliferation Inducing Ligand (APRIL), which stimulate B cells to produce autoantibodies contributing to certain autoimmune diseases, including IgA nephropathy. Vera is also evaluating the role of atacicept in other immunologic disorders. Additionally, Vera is developing VT-109, a novel, next-generation dual BAFF/APRIL inhibitor in preclinical development, and MAU868, a monoclonal antibody designed to neutralize infection with BK virus, a polyomavirus that can have devastating consequences in certain settings such as kidney transplant. For more information, please visit: www.veratx.com. Our values are the cornerstone of our culture. Our values inspire us every day and guide everything we do—from how we hire great people, to advancing our mission together, to achieving our ultimate goal to improve medical treatment for patients suffering from immunological diseases. Position Summary: QA Document Control and Training Specialist will report to the Senior Director, Quality Systems and Compliance and will be responsible for overseeing the day-to-day operations of the Document Control and Training systems. This role requires close collaboration with cross-functional teams to ensure compliance with regulatory requirements and internal quality standards. The ideal candidate will be a proactive subject matter expert (SME) with proven experience in managing document lifecycle processes, training programs, and quality systems within a pharmaceutical or regulated environment.

Requirements

• 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 and Experience with Veeva is a plus.
• 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.

Nice To Haves

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

Responsibilities

• Document Control Management:
• 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).
• Training Program Oversight:
• 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).

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 251-500 employees