Our Mission

Aurinia exists to make a difference in transforming people’s lives by delivering innovative treatments to patients living with serious, rare autoimmune and inflammatory diseases. From the earliest days of the company, we’ve applied an inventive, thoughtful, and responsible approach to developing therapies for people in need. Through our dedication, we relentlessly preserve and execute with integrity to reach our main objective, to improve patients’ health.

In addition to driving adoption of our approved therapy, LUPKYNIS™, for appropriate people with lupus nephritis, we are also actively pursuing a broader portfolio of innovative drugs for autoimmune disease.

Our strategy leverages the skills and knowledge of our incredible team and our deep experience in principled drug development and commercialization. Aurinia provides a working environment where individuals can thrive in a professional, creative, and inspirational atmosphere. Together, we are driven to make an impact for our patient communities as advocates and partners in innovation.

We are looking for a Commercial Quality Assurance Specialist to join our Quality Assurance team who can provide broad advocacy for the continued improvement of quality standards and the development and maintenance of a quality culture across the organization as we undertake our first US product launch. This is an exciting time to join Aurinia in either a remote or in-office capacity. Assisting and supporting with all elements of commercial QA Quality Management System (QMS), including but not limited to document and record control, investigations, corrective action tracking & trending, risk management, quality metrics, document and batch record reviews, change controls, deviations, customer complaints, recalls, and vendor management are key to this role.

Primary Responsibilities:

• Supports QA commercial objectives for oversight of vendors including the call center, pharmacovigilance, patient services, and the supply chain including specialty pharmacies and specialty distributors.
• Develops, reviews and maintains Standard Operating Procedures (SOPs), and other documentation and training materials related to GXP compliance and other applicable requirements.
• Ensures review of all quality documents via the applicable computer system, i.e. change controls, deviations, investigations, audit reports, complaint files, batch records, CofAs, testing results, notes to file. Ensures all documents are accurate, organized, filed and transferred to the appropriate document management system.
• Supports customer complaints, including coordinating the investigation and follow-up to ensure timely completion.
• Supports external and internal audits, including planning, conducting, preparing/reviewing/finalizing internal audit reports, and ensuring proper closure of any observations.
• Supports the change control process to ensure all manufacturing and testing processes remain in a state of control and align with the current submission.
• Contributes to risk assessments and ensures all resulting activities are closed out as described.
• Reviews executed Batch Records (BRs) and releases material for clinical or commercial use.
• Assists in the preparation of Management Reviews, Annual Product Reviews, and Site Quality Review.
• Supports implementation of quality related projects as assigned.
• Assists in providing GxP training to Aurinia staff, completes Standard Operation Procedures training.

• Bachelor’s degree
• 3-5 years of relevant work experience, preferably in a QA related role of a pharmaceutical company
• Thorough knowledge of current Good Manufacturing Practices regulations (cGMP) and technical knowledge of pharmaceutical processes, as well as of quality control and quality assurance concepts.
• Working Knowledge of the different pharmacopoeias (USP, BP, EP, etc.)
• Experience and understanding of Veeva Vault is preferred
• Strong working knowledge of Microsoft applications
• Ability to deliver clear, effective communication orally and in writing and takes responsibility for understanding others
• Thrives in an environment with tight deadlines and manages oneself with a sense of initiative and urgency
• Assumes responsibility for successfully accomplishing work objectives and has proven experience in delivering results and making quick informed decisions
• 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 and coordinate several projects at once

All candidate information will be kept confidential according to EEO guidelines