This position 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. As an integral member of this team, you will collaborate with various inter-site and intra-site departments to maintain compliance with global Health Authority regulations and contribute to regulatory inspection readiness. 

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.  Additionally, you will:

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

Who You Are:

Bachelor’s degree or equivalent (as proven by at least 4 years of related experience) 

At least 3 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

Preferred Experience:

Experience in Veeva 

Strong technical writing ability

Relocation benefits are not approved for this posting.
This is an on-site role; no remote options will be considered.

The expected salary range for this position based on the primary location of Oregon is $75,000 - $139,400. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law.  A discretionary annual bonus may be available based on individual and Company performance.  This position also qualifies for the benefits detailed at the link provided below.

Benefits

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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.