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).
The Opportunity
Document Lifecycle Management: Coordinate activities including editing, printing, routing, and archiving through the Electronic Document Management System (EDMS).
Shop Floor Support: Perform work within the cleanroom environment, requiring the ability to maintain gowning qualification and adhere to strict aseptic protocols.
Operational Control: Issue GMP-controlled documents to relevant departments and execute the Print for Reconciliation (PfR) process to ensure proper archival.
Compliance Oversight: Maintain the Periodic Review Process for released documents and ensure adherence to Document and Records Management policies.
Strategic Representation: Represent Quality on cross-functional teams, providing training to internal customers on Document Control procedures.
Continuous Improvement: Utilize your expertise to simplify systems, ensuring efficiency while fostering an engaging, safety-conscious work environment.
Audit Support: Act as a Subject Matter Expert (SME) and presenter for Document Control during health authority inspections and internal audits.
Who You Are
Education & Experience: You hold a Bachelor’s degree in a scientific discipline with at least 3 years of experience in the (bio)pharmaceutical industry, including knowledge of cGMP and SOPs in a manufacturing environment.
Quality Mindset: You possess an unwavering commitment to quality, ensuring that every task—from document control to cleanroom operations—is executed with the highest level of integrity and compliance.
Critical Thinking: You demonstrate a strong aptitude for critical thinking, with the ability to analyze complex processes, identify potential risks, and implement simplified, effective solutions.
Technical Proficiency: Strong knowledge of Quality systems and cGMP regulations. Previous experience with Veeva or similar EDMS is preferred.
Communication & Influence: Excellent communication skills with the ability to influence stakeholders at all levels and address the needs of diverse teams.
Detail Orientation: Proven ability to prioritize multiple projects simultaneously while maintaining a high level of accuracy.
Physical Requirements
Cleanroom Access: Must be able to pass and maintain gowning qualification to work in Grade C/D (or higher) cleanroom environments.
Office & Lab Environment: Work in an office setting with the ability to sit, stand, and move within the workspace for extended periods.
Manual Handling: Ability to lift up to 25 lbs as required.
Relocation benefits are not approved for this posting.
This is an on-site role; remote options are not available.
The expected salary range for this position based on the primary location of Oregon is $68,800 - $127,800. 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.
#LI-CA1
#ptcareers
#cellandgenetherapycareers#
Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws.
If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants.