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Under supervision and guidance, the Quality System Analyst is responsible for supporting improvements through implementation and oversight of the Change Management (Change Control) process within the Adaptive Quality Management System (QMS). Change Control is a process that manages modifications to products, services, or processes in accordance with design specifications, manufacturing requirements, and risk management, including applicable regulations and standards. The incumbent will cross-functionally interface with departments to ensure efficient implementation of requirements and/or standards including, but not limited to, FDA/ISO and CAP/CLIA. The role requires the ability to manage a project and its activities utilizing effective written and oral communication skills. The intern will develop and apply national and international Quality Systems regulatory knowledge, reasoning, and judgment skills to ensure appropriate checks and balance of quality, compliance, and business needs. Ideal candidates will combine technical and business knowledge with analytical strength and creative problem-solving abilities. The goal of the internship is to learn about working in a corporate setting and to provide hands-on experience solving real world problems in a team environment.
- Lead the development and improvement of processes and metrics related to Change Management, including creation of tools or training to support the activity
- Solicit feedback from key stakeholders to identify user needs to define a problem, measure performance, analyze sources for causes, and implement a solution
- Support development, analysis, and reporting on Quality Information System business intelligence metric(s) / key performance indicator(s) to drive implementation of continuous improvement opportunities to provide value for the organization
- Act as project lead for a Lean Six Sigma project utilizing DMAIC framework to drive process performance improvements. Project will focus on an area of Quality that will require active collaboration with cross-functional departments to meet desired goal
- Document and present project outcome and proposed solutions to management at the end of the internship
- Support other Quality System ad hoc assigned tasks, as needed
- Must be currently enrolled in a Bachelor’s degree program in Science, Technology, Engineering, or Mathematics discipline, with an expected graduation date of Fall 2021 or Spring 2022
- Prior work experience
- Must possess strong ownership characteristics and commitment to achieving results on time which includes problem solving skills and the ability to recognize to take initiative to control outcomes
- Must be involved in at least 1 extracurricular activity
- Able to recognize mistakes, learn from them, be able to debate openly, and be open to other people’s ideas
- Must be legally authorized to work in the United States. Verification of employment eligibility will be required at time of hire. Visa sponsorship is not available for this position
- Should have a growth mindset
- Should have a 3.0+ GPA
Adaptive Biotechnologies is proud to be an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability. Equal Opportunity Employer/Veterans/Disabled