Quality Assurance Specialist
11 hours ago
This role is part of Genentech's Hillsboro Innovative Therapies (HIT) Quality Systems (QS) team dedicated to ensuring the highest standards of document management and control for innovative cell therapies.
The Opportunity:As a Quality Assurance Specialist, you will play a pivotal role in managing and controlling documentation, ensuring compliance with global regulations and supporting continuous improvement initiatives.
Key Responsibilities:- Coordinate document management activities including editing, printing, routing, storage, and maintenance using the Electronic Document Management System (EDMS)
- Maintain oversight of the Periodic Review process for released documents and ensure compliance with Document and Records Management policies
- Coordinate and execute the Print for Reconciliation (PfR) process to ensure the proper retrieval and archival of specified GMP documents
- Represent Quality on cross-functional and multi-site teams, ensuring efficient execution of document control activities
- Provide training to new employees and internal customers on policies and procedures for the Change and Document Control systems
- Support regulatory inspections and audits, including serving as a presenter for Document Control or Records Management systems as needed
- Bachelor's degree or equivalent (as proven by at least 4 years of related experience)
- At least 2 years of experience in a Quality role within the pharmaceutical or biopharmaceutical industry, specifically in document control within a GMP environment, with knowledge of GMP, SOPs, and compliance requirements in a manufacturing setting
- Strong technical knowledge of biopharmaceutical manufacturing process and equipment
- Demonstrated stakeholder management skills with a proven track record of collaborating effectively in a matrixed environment
- Excellent organizational and communication skills, with a keen attention to detail
- Ability to prioritize multiple tasks and projects simultaneously while maintaining a high level of accuracy and compliance
- Proven capability for systems thinking, with strong social skills and an emphasis on understanding and addressing the needs of various customers
- Experience in Veeva
- Strong technical writing ability
Genentech is an equal opportunity employer, and we embrace the increasingly diverse world around us. Genentech prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin or ancestry, age, disability, marital status, and veteran status.
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