Roche · 1 month ago
QA Specialist II/III, Customer Complaints
Hillsboro
Full-time
Onsite
Mid, Senior Level
$77K/yr - $143K/yr
4+ years expRoche is a leading pharmaceutical company, and they are seeking a QA Specialist II/III to join their Hillsboro Technical Operations team. The role involves leading investigations for customer complaints and critical deviations while providing quality oversight for commercial production.
BiotechnologyHealth CareHealth DiagnosticsOncologyPharmaceuticalPrecision Medicine
Responsibilities
You will act as lead investigator for complaints, critical deviations and the associated escalation process
You will be a mentor and coach for the organization and the network and you will provide quality oversight for our commercial production and the complaints at the Hillsboro site
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
You have a BS/MS Master's degree (Life Sciences or Engineering, preferred) and significant relevant bio/pharmaceutical experience in a Good Manufacturing Practices environment (Drug Product and/or Device preferred)
You have 4+ years (level II) and 8+ years (level III) of industry experience preferably in a biologics manufacturing environment
You are able to deliver business outcomes in support of departmental and site objectives
You are able to work in an agile organization, flow to work and apply skills where resources are needed
You have sound knowledge of cGMP, ISO standards and international regulations for pharmaceuticals. Ability to interpret quality standards as they relate to commercial manufacturing
You have excellent communication skills and are able to gown into production space
Benefits
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.
This role is eligible for relocation benefits.
Company
Roche
Roche is a pharmaceutical and diagnostics company that offers medicines and diagnostic tests for various medical conditions and diseases.
10001+ employees
H1B Sponsorship
Roche 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 (12)
2024 (9)
2023 (6)
2022 (2)
2021 (2)
Funding
Current Stage
Public CompanyTotal Funding
$7.79BKey Investors
SoftBankSCALE AINovartis
2021-08-04Post Ipo Equity· $5B
2020-12-07IPO
2020-05-06Post Ipo Equity· $0.5M
Leadership Team
Alan Hippe
Member of the Executive Board - Group CFO
Christine Bakan
Global Head and Group Vice President, Computational Science and Informatics R&D
Recent News
2026-01-23
2026-01-22
Company data provided by crunchbase