Quality Assurance Specialist II

At Aldevron, we shape the future of medicine by advancing science in meaningful ways. Our team of dedicated, forward-thinking associates share this goal by combining best-in-class products and service with the ideal operating environment to lay the groundwork for vital new discoveries worldwide. We believe people are our most valuable asset. Whether this is your first step on a rewarding career path or are a seasoned professional ready to take your career to the next level, we hire the best from all backgrounds and experiences.

Aldevron is one of 10 Life Sciences companies of Danaher. Together, we accelerate the discovery, development and delivery of solutions that safeguard and improve human health.

This position is part of the Quality Department located in Madison. Wisconsin and will be on-site. At Aldevron, we combine best-in-class products and service with the ideal operating environment to lay the groundwork for vital new discoveries worldwide. You will be a part of the Quality Assurance team and report to the Director of Quality. In this role you will be responsible for raw material inspections, product release, documentation review and approval as well as have the opportunity to work on improvement projects.  

In this role you will have the opportunity to:  

• Supports maintaining quality standards, processes and controls; participates in quality improvement initiatives and supports internal and external quality audits.
• Collaborates with QA associates to accomplish all daily QA tasks timely and with high level of quality. Supports cross functional teams to ensure compliance to the quality standard.
• Reviews and approves root cause investigations and actions to mitigate risks, eliminate recurrence, and ensures appropriate deliverables are met per the defined process. Further, reviews approves documents including Batch Records, PM and Calibration activities, validation records (equipment, process and assay validations), as well as other quality records.

The essential requirements of the job include:

· Minimal requirement is a High School diploma.

· 2+ years of Quality Assurance experience in an ISO 13485 and/or GxP environment

It would be a plus if you also possess previous experience in:

· BA degree in science or related field or equivalent experience

· QMS, training in Quality systems, management of Quality System procedures and related documentation. Strong technical writing and root cause analysis skills

At Danaher we bring together science, technology and operational capabilities to accelerate the real-life impact of tomorrow’s science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life. Our global teams are pioneering what’s next across Life Sciences, Diagnostics, Biotechnology and beyond. For more information, visit www.danaher.com.

Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. We value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.

The EEO posters are available here.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform crucial job functions, and to receive other benefits and privileges of employment. Please contact us at [email protected] to request accommodation.