Quality Assurance Specialist, GXP (Contractor)

Your work will change lives. Including your own. 

Expect more from your next Quality Assurance role! 

What if Quality Assurance could be positioned as a force for supporting positive change? What if they were partners in creating positive outcomes for patients rather than the “compliance cops”? Can QA do more to help protect patients beyond auditing and annual compliance training? 

In service of Recursion’s mission to decode biology and radically improve lives, we asked ourselves, “what would it take to make QA a driver of meaningful and positive change?” 

The answer was to design our QA function not as a hurdle for others to navigate or overcome, but as a partner in assuring patient safety, product quality, and data integrity across the organization. It starts with a willingness to re-examine old thinking and methodologies, rejecting blind adherence to checklists and any activities that are only justified because  ”it’s the way it's always been done.” 

Quality Assurance at Recursion thinks in terms of process and outcomes and is driven by purpose. The people we hire are successful here not because they know all the answers but because they think through situations and work with their partners to find the best answers. Without a consensus-driven or “this is the way it’s always been done” mentality, you will have the opportunity to work with the QA team and our partners to  influence the way that we support compliance at both investigator sites and within Recursion.. This kind of empowerment to interpret and apply the true meaning of requirements can be uncomfortable at times because it feels like working without a net. But together, side-by-side with our partners in data, science, and medicine, we’re artists and scientists for the sake of assuring patient safety, product quality, and data integrity.

Hear more from the Head of Recursion’s Quality Assurance team:

The Impact You’ll Make

• Promote internal compliance to Standard Operating Procedures and Regulations. You will work with the Quality Systems team to advance a Quality Management System (QMS) that is created to serve and enable employees working within the system, resulting in optimized and compliant outcomes.
• Support the development of a risk-based, fit-for-purpose GXP QMS. You will be asked to collaborate across all development functions (including nonclinical, clinical, and CMC) to build and implement phase-appropriate and applicable quality systems that support Development activities.
• Participate in the implementation and maintenance of an electronic Quality Management System (eQMS). Become a subject matter expert in managing user accounts, coordinating training with SMEs/Stakeholders, and managing controlled documents. Work with our external eQMS business partner to assist in the deployment of modules to come onboard the eQMS, such as CAPAs, Audits, and Vendor Management. 
• Assist in the development and implementation of an internal Quality Assurance program. As a member of the team, you’ll collaborate with QA and Clinical Development colleagues to design and implement right-sized quality oversight initiatives to support, enable, and accelerate clinical development. You’ll maintain collaborative, integrated, and productive relationships with internal stakeholders, fellow team members, and external vendor-partners to assure appropriate regulatory oversight is maintained.

The Team You’ll Join 

• You will be joining a dynamic Quality Assurance team at Recursion, which includes Preclinical QA, Clinical QA, CMC QA, and Quality Systems. Reporting to the Associate Director, Quality Systems, you will bring GXP expertise and creative ideas to the organization.  

The Experience You’ll Need

• Bachelor’s degree in a life science field, or equivalent, with 2+ years in Quality Assurance within the pharmaceutical/biotech industry, including 2+ years in a Document Management role.
• Knowledge of the drug development life cycle preferred
• Experience in planning and conducting QA oversight activities in an outsourced environment using risk-based approaches
• Demonstrated ability to thrive, both strategically and tactically, in a multi-disciplinary environment using a first principles approach
• Experience working in electronic quality management systems
• Ability to work 30-40 hours per week

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The Values That We Hope You Share:

• We Care: We care about our drug candidates, our Recursionauts, their families, each other, our communities, the patients we aim to serve and their loved ones. We also care