Systems & Process Intern

Team Description:

Join our Quality team, where our mission is to ensure compliance with relevant regulatory standards by streamlining operations and enhancing efficiency through innovative process development. We are a group of industry-experienced professionals who utilize creative problem-solving to establish efficient systems for compliance. Our vision is to develop internal quality standards that exceed the FDA's expectations and requirements. We seek a dynamic individual with interdisciplinary skillsets who thrives on continuous improvement and is passionate about implementing systems that drive compliance and optimize performance. You will have the opportunity to work cross-functionally to scale the speed and throughput of our company activities.

Job Description and Responsibilities:

Your primary responsibility will be to gather requirements and develop processes with compliance built into their design. These processes will eliminate variables, save time, and reduce costs, thereby facilitating rapid iteration and innovation. You will continually optimize and improve these processes to enhance efficiency over time, transitioning from one method to another as they are developed and refined. Processes may encompass various areas, such as data governance, nonconformance management, document control, automation of audits and reporting, testing, and others, as they pertain to preclinical, clinical, and manufacturing activities.

• Drive process improvements to enhance systemic compliance and quality standards, utilizing ingenuity and creative problem-solving skills.
• Design systems that increase efficiency, utilize automation, and assess the impact of changes on existing workflows.
• Build software within and outside of a lab management system. Assist in maintaining, querying, and analyzing data.
• Develop dashboards that automatically display quantifiable metrics in real-time.
• Assist with deviation and audit findings, tracking, ensuring their effective execution, and coordinating the timely closure of actions.
• Demonstrate excellent people skills while collaborating with multiple teams that have diverse communication styles. 
• Be an exceptional communicator who can effectively translate user needs into design requirements.
• Apply experience in solutions architecture, logistics, project timelines, milestones, and resource management to frameworks.
• Gain a thorough understanding of multidisciplinary domains to inform process design.

In this role, you will work extensively with Jira to create new systems and processes that are self-sustainable and primarily automated. You will collaborate with inter- and intra-team stakeholders to gather requirements, identify pain points, and build solutions from scratch. Examples of projects include developing automated report generation tools, auto-notification systems, and issue ticketing processes.

Required Qualifications:

• Strong understanding of engineering first principles and operations engineering.
• Fundamental understanding of how systems work
• Experience designing and implementing software solutions, analyzing data, and creating dashboards.
• Proficient in at least one general-purpose programming language (e.g., Python, Ruby, C++, Java).
• Proficient with Excel or G Suite.
• Able to apply solutions architecture concepts to lead/drive projects to completion.
• Ability to identify and resolve inefficiencies in processes.
• Meticulous attention to detail and organizational skills leading to thoughtful designs, but you know that what matters is delivering an implementable solution that works every time.
• Effective collaboration in a cross-disciplinary team environment.
• Pursuing a STEM degree or equivalent experience.

Preferred Qualifications:

• Experience designing/running tests for a complex system.
• Experience with Operational Excellence projects.
• Understanding of quality, surgery, animal research, neuroscience, and/or engineering.
• Background in Systems Engineering, Computer Science, Bioengineering, or related field.

Pay Transparency:

Based on California law, the following details are for California individuals only:

California Hourly Rate:

$28/hr USD