Genentech · 20 hours ago
QA Specialist II/III, Customer Complaints
Hillsboro, OR
Full-time
Onsite
Mid, Senior Level
$77K/yr - $143K/yr
4+ years expGenentech is a drug product and finished goods manufacturing organization responsible for the reliable delivery of Roche’s commercial portfolio and pipeline products. In this role, you will act as lead investigator for complaints and critical deviations, providing quality oversight and mentoring within the organization while ensuring compliance with regulatory standards.
BiotechnologyLife ScienceManufacturing
Responsibilities
You will lead complaints and critical deviations with minimal guidance and ensure investigation action plans and final investigation summaries are accurate, include appropriate corrective actions and follow company standards
You will own and/or support complaint trending activities including, but not limited to annual product quality reviews and quarterly trending reports
You will collaborate with departments (e.g. Affiliates, Manufacturing sites, external quality, quality control etc.) to establish appropriate, efficient, and timely investigation plans
You will notify senior management of potential quality or regulatory issues that may impact product quality or regulatory compliance
You will communicate new and updated regulatory requirements and evaluate systems in place
You will support internal cGMP audits and Health Authority inspections as needed, and follow up on any corrective measures
You will solve complex problems; both inside and outside of the quality organization
You will work independently within standard guidelines, policies and health authority regulations and mentor others
You will serve as primary consultant to senior management and internal/external spokesperson for the organization
Qualification
Required
BS/MS Master's degree (Life Sciences or Engineering, preferred)
Significant relevant bio/pharmaceutical experience in a Good Manufacturing Practices environment (Drug Product and/or Device preferred)
4+ years (level II) and 8+ years (level III) of industry experience preferably in a biologics manufacturing environment
Ability to deliver business outcomes in support of departmental and site objectives
Ability to work in an agile organization, flow to work and apply skills where resources are needed
Sound knowledge of cGMP, ISO standards and international regulations for pharmaceuticals
Ability to interpret quality standards as they relate to commercial manufacturing
Excellent communication skills
Ability to gown into production space
Benefits
A discretionary annual bonus may be available based on individual and Company performance.
This role is eligible for relocation benefits.
Company
Genentech
Genentech is a biotechnology research company that specializes in genetic testing and personalized medicines.
10001+ employees
H1B Sponsorship
Genentech has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (167)
2024 (148)
2023 (150)
2022 (178)
2021 (121)
2020 (158)
Funding
Current Stage
Public CompanyTotal Funding
unknown2009-03-26Acquired
1999-07-20IPO
1976-01-01Series Unknown
Leadership Team
Ashley Magargee
Chief Executive Officer
Michael Laird
Vice President
Recent News
2026-01-07
MarketScreener
2026-01-06
Company data provided by crunchbase