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Quality Assurance Engineer
Science 37 is accelerating the research and development of breakthrough biomedical treatments by bringing clinical trials to patients' homes. Backed by venture investors such as Glynn Capital, Google Ventures, Redmile Group, dRx Capital and Lux Capital, we are revolutionizing the clinical trial industry one patient at a time. To help us achieve our goal, we are seeking a razor-sharp Quality Assurance Engineer eager to make an impact within a mission-driven organization. ****
The Quality Assurance Engineer will be responsible for ensuring the overall compliance for GxP systems developed / utilized at Science 37. Science 37 has developed a cloud based clinical research platform that is used by both external and internal staff to run distributed clinical trials. The Quality Assurance Engineer will be evaluated based on your ability to support quality compliance operations for the clinical research platform.
On a day-to-day basis the Quality Assurance Engineer will be hands on with the Product Management, Technology and Testing teams and following our software development lifecycle. The Quality Assurance Engineer be assisting our testing and validation teams in drafting validation documentation for compliance and regulatory requirements.
Duties include but are not limited to:
- Assure quality systems are followed and integrated with business processes and aligned with Science 37 and external regulatory requirements
- Provide interpretation, guidance, and training regarding qualification and validation requirements in GxP.
- Apply Quality Engineering/Scientific Method techniques and principles to daily tasks and activities. In addition, applies relevant regulations, standards, GxP requirements, and industry best practices to assignments.
- Participate in project teams and author (as applicable), review and approve computer validation related documentation including but not limited to: risk assessments, validation plan, user requirements, specifications, UAT, traceability matrix, testing (FAT, SAT, IQ,, OQ/PQ), data migration, qualification/validation protocols and reports.
- Participate/lead in the review of current and future SDLC/CSV policies and procedures.
- Support initiatives related to audit readiness, management of internal audits and regulatory inspections, and responding to findings in areas of responsibility.
- Demonstrate strong proficiency in applying established tools and methods (for example, Six Sigma, Lean) to identify and realize new product or process introductions, as well as process and business improvements.
- Implement, and/or maintain process Quality control plans that are in accordance with product or process risk level, and ensures those plans are consistently followed.
- Support execution of strategic vision or plan by collaborating with cross functional teams to identify required Quality Engineering skills and competencies.
- Actively coach talent across the tech organization on quality principles.
- Partner with training to prepare user documentation and training materials.
Qualification and Skills
- Bachelor’s degree or higher in computer science or biotechnology discipline or equivalent experience. Minimum of 3 to 5 years related experience.
- Deep knowledge of regulatory requirements (21 CFR Part 11, EU GMP Annex 11 / 15, ICH, PIC/S) and Best Practices (GAMP5, etc.).
- Experience in Agile software delivery
- Strong problem-solving and communication skills (both written and verbal)
- Strong teamwork and interpersonal skills
The incumbent reports to the Director of Quality Assurance who will also assign projects, provide general direction and guidance. Incumbent is expected to perform duties and responsibilities with minimal supervision.
Science 37 values the well-being of its employees and aims to provide team members with everything they need to succeed.
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Science 37 at a glance
Science 37 focuses on Mobile, Information Technology, Health Care Information Technology, Software, and Technology. Their company has offices in Los Angeles, Culver City, and Playa Vista. They have a mid-size team that's between 51-200 employees. To date, Science 37 has raised $107.5M of funding; their latest round was closed on March 2018.