Our Mission: Changing the trajectory of autoimmune diseases.
Our Vision: Enabling patients to live their fullest life.
We are a dedicated team of experts committed to changing the trajectory of autoimmune diseases with unmet medical needs. We are relentless in our pursuit to provide transformative medical treatments. We are resilient. We Care.
Along with driving adoption of our approved therapy, LUPKYNIS™, for appropriate people with lupus nephritis, we are pursuing a broader portfolio of innovative autoimmune disease therapies.
We provide high quality products to our patients, that are safe and effective. Each of us at Aurinia own Quality, and we proactively integrate Quality into everything that we do. Exceptional quality and regulatory compliance are essential to our business, and “We Care” so that patients can take our drugs with confidence.
Our strategy leverages the skills and knowledge of our expert team and our deep experience in principled drug development and commercialization. Aurinia’s working environment enables every individual to thrive in a professional atmosphere guided by our Culture Values:
- Achieve together
- Collaborate
- Explore & build
- Act responsibly
Together, we drive to change the trajectory of autoimmune disease for patients in need.
Overview
We are looking for a Clinical QA Specialist to join our Quality Assurance team who can provide broad advocacy for the continued improvement of quality standards and a quality culture across the organization.
Responsibilities:
- Supports QA oversight and GCP compliance of all study activities, working in close collaboration with Aurinia cross-functional teams and CRO teams
- Performs study audits as per audit plan and study needs (sites, systems, vendors, documents, etc.)
- Supports the assembly, maintenance, and archiving of study TMFs and their systems
- Ensures continued qualifications of GCP related vendors and systems
- Supports study and GCP related Deviations, Quality Issues, CAPA, and Root Cause Analysis processes
- Supports Serious Breach related processes and reporting
- Works in partnership with related GxP functions incl. operating within an aligned QMS while maintaining compliance with regulatory requirements
- Participates in ongoing Inspection Readiness efforts
- Advises stakeholders on GCP Compliance issues and questions
- Prepares KPIs for performance monitoring and Management Oversight.
- Contributes to the development of QA and GCP related procedures (SOPs).
- Assists in providing GxP training to Aurinia staff.
- Supports departmental GxP related activities and projects
Skills:
- Bachelor’s degree, preferably in health-related sciences
- Minimum of 1 - 3 years of relevant technical experience in the pharmaceutical industry
- Thorough knowledge of ICH Good Clinical Practices (GCP)
- Thorough knowledge of US and International GCP related regulations
- Functional knowledge of GMP requirements, especially IMP GMP
- Understanding of Computer System Validation / Assurance requirements (CSV/CSA)
- Clinical Good Laboratory Practice (cGLP) knowledge, preferred
- Ability to deliver clear, effective communication orally and in writing (in English)
- Ability to work independently as well as in a team environment
- Attentive to the details, able to recognize critical attributes, steps and functions
- Well-organized, able to switch priorities quickly, coordinate several tasks at once and make quick informed decisions
- Strong working knowledge of Microsoft applications
- Ability to consistently exhibit Aurinia’s We Care values of creating opportunity, acting responsibly, relentlessly persevering, and executing with integrity in all work and interactions with employees at all levels of the organization, as well as with vendors and customers
Additional Information
All candidate information will be kept confidential according to EEO guidelines.
