Quality Assurance Specialist (Document Control)

Genentech•Hillsboro, OR

1d•Onsite

About The Position

The QA Specialist is an integral part of Genentech’s Hillsboro Innovative Therapies (HIT) Compliance and Document Control team, dedicated to ensuring the highest standards for innovative cell therapies. In this role, you will collaborate with inter-site and intra-site departments to maintain compliance with Roche/Genentech policies and Health Authority regulations. You will play a crucial part in maintaining a state of inspection readiness, covering a broad range of topics including Quality, Safety, Health and Environmental Services (SHE), training, and the Quality Management System (QMS).

Requirements

Bachelor’s degree in a scientific discipline with at least 3 years of experience in the (bio)pharmaceutical industry.
Knowledge of cGMP and SOPs in a manufacturing environment.
Unwavering commitment to quality, ensuring that every task is executed with the highest level of integrity and compliance.
Strong aptitude for critical thinking, with the ability to analyze complex processes, identify potential risks, and implement simplified, effective solutions.
Strong knowledge of Quality systems and cGMP regulations.
Excellent communication skills with the ability to influence stakeholders at all levels and address the needs of diverse teams.
Proven ability to prioritize multiple projects simultaneously while maintaining a high level of accuracy.
Must be able to pass and maintain gowning qualification to work in Grade C/D (or higher) cleanroom environments.
Ability to sit, stand, and move within the workspace for extended periods.
Ability to lift up to 25 lbs as required.

Nice To Haves

Previous experience with Veeva or similar EDMS is preferred.

Responsibilities

Coordinate activities including editing, printing, routing, and archiving through the Electronic Document Management System (EDMS).
Perform work within the cleanroom environment, requiring the ability to maintain gowning qualification and adhere to strict aseptic protocols.
Issue GMP-controlled documents to relevant departments and execute the Print for Reconciliation (PfR) process to ensure proper archival.
Maintain the Periodic Review Process for released documents and ensure adherence to Document and Records Management policies.
Represent Quality on cross-functional teams, providing training to internal customers on Document Control procedures.
Utilize your expertise to simplify systems, ensuring efficiency while fostering an engaging, safety-conscious work environment.
Act as a Subject Matter Expert (SME) and presenter for Document Control during health authority inspections and internal audits.