Vera Therapeutics, Inc.
QA Document Control and Training Specialist
Vera Therapeutics, Inc., Brisbane, California, United States, 94005
QA Document Control and Training Specialist
Brisbane, CA
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 BAFF and APRIL, which stimulate B cells to produce autoantibodies contributing to certain autoimmune diseases, including IgA nephropathy.
Position Summary The QA Document Control and Training Specialist reports to the Senior Director, Quality Systems and Compliance and is responsible for overseeing the day-to-day operations of the Document Control and Training systems. The role requires close collaboration with cross-functional teams to ensure compliance with regulatory requirements and internal quality standards.
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).
Qualifications
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, Microsoft Excel, and Adobe Acrobat are a must.
Experience supporting audits and regulatory inspections with strong knowledge of data integrity and compliance best practices is a plus.
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.
Compensation Vera Therapeutics is committed to fair and equitable compensation practices and we strive to provide employees with total compensation packages that are market competitive. The anticipated base pay range for this role is $90,000 - $115,000 USD.
Vera Therapeutics Inc. is an equal‑opportunity employer.
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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 BAFF and APRIL, which stimulate B cells to produce autoantibodies contributing to certain autoimmune diseases, including IgA nephropathy.
Position Summary The QA Document Control and Training Specialist reports to the Senior Director, Quality Systems and Compliance and is responsible for overseeing the day-to-day operations of the Document Control and Training systems. The role requires close collaboration with cross-functional teams to ensure compliance with regulatory requirements and internal quality standards.
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).
Qualifications
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, Microsoft Excel, and Adobe Acrobat are a must.
Experience supporting audits and regulatory inspections with strong knowledge of data integrity and compliance best practices is a plus.
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.
Compensation Vera Therapeutics is committed to fair and equitable compensation practices and we strive to provide employees with total compensation packages that are market competitive. The anticipated base pay range for this role is $90,000 - $115,000 USD.
Vera Therapeutics Inc. is an equal‑opportunity employer.
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