QA Lead Specialist

Danaher

Madison, Wisconsin

JOB DETAILS
SKILLS
Biochemistry, Biology, Biotech and Pharmaceutical, Business Solutions, Continuous Improvement, Corrective and Preventative Action (CAPA) Systems, ERP (Enterprise Resource Planning), Genomic Medicine, GxP, ISO (International Organization for Standardization), Internal Audit, Lean Manufacturing, Mentoring, Performance Analysis, Performance Metrics, Quality Assurance, Quality Management, Root Cause Analysis, Schedule Development, Standard Operating Procedures (SOP), Team Player, Technical Writing, Writing Skills
LOCATION
Madison, Wisconsin
POSTED
28 days ago

Bring more to life.

Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology?

At Aldevron, one of Danaher’s 15+ operating companies, our work saves lives—and we’re all united by a shared commitment to innovate for tangible impact.

You’ll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher’s system of continuous improvement, you help turn ideas into impact – innovating at the speed of life.

At Aldevron, we deliver world-class CDMO services that accelerate the development of groundbreaking therapies. Our mission is to be the engine of innovation for genomic medicine pioneers. As a member of our team, you’ll help bring life-changing innovations to life—impacting millions around the world. We bring together deep scientific expertise, an unwavering commitment to quality, and a collaborative spirit to drive progress. Whether you're launching your career or bringing years of experience, we value the unique perspective you bring. Join us and become part of a mission-driven team advancing science and unlocking human potential—one discovery at a time.

Learn about the Danaher Business System which makes everything possible.

This position is part of the Quality Assurance department located in Madison, WI and will be an on-site position. At Aldevron, we combine best-in-class products and service with the ideal operating environment to lay the groundwork for vital new discoveries worldwide. As a member of the Quality Assurance team, you will report to the Quality Manager and serve as a peer leader and Subject Matter Expert. In this role, you will lead deviation and CAPA activities, and oversee the review and release of final products.

In this role, you will have the opportunity to:

  • Lead, mentor, and train Quality Assurance staff, serving as the subject matter expert
  • Lead quality events and CAPAs, drive to root cause, and contribute to continuous improvement initiatives
  • Author, maintain, and continuously improve SOPs Quality Systems and Quality Assurance
  • Create the working schedule for Quality Assurance staff, review and monitor daily work, and track weekly performance metrics
  • Provide front-room support during audits (ISO 13485, internal, and client audits)

The essential requirements of the job include:

  • 6 years experience in an ISO 13485 and/or GxP environment
  • 3 years experience with root cause analysis and/or technical writing
  • Bachelor of Science in Biology, Biochemistry, or related field required

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

  • MasterControl eQMS and Dynamics 365 ERP software
  • Background in Continuous Improvement and/or Lean Manufacturing

Aldevron, a Danaher operating company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives. Whether it’s a health care program or paid time off, our programs contribute to life beyond the job.

This job is also eligible for bonus/incentive pay.

We offer comprehensive package of benefits including paid time off, medical/dental/vision insurance and 401(k) to eligible employees.

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole discretion unless and until paid and may be modified at the Company’s sole discretion, consistent with the law.

Join our winning team today. Together, we’ll 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.


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.


The U.S. EEO posters are available here.


For candidates who are based outside of New York City or who are applying for roles outside of New York City, for more information about conditions of any job offer please click here.


We comply with federal and state disability laws and make reasonable accommodations for applicants and employees with disabilities. If reasonable accommodation is needed to participate in the job application or interview process, to perform essential job functions, and/or to receive other benefits and privileges of employment, please contact:1-202-419-7762 or

applyassistance@danaher.com

.

About the Company

D

Danaher

Danaher is a global science & technology innovator committed to helping our customers solve complex challenges and improve quality of life worldwide. Our world class brands are leaders in some of the most demanding and attractive industries, including life sciences, medical diagnostics, dental, environmental and applied solutions. Our globally diverse team of 71,000 associates is united by a common culture and operating system, the Danaher Business System, which serves as our competitive advantage. We generated $19.9B in revenue last year. We are ranked #162 on the Fortune 500 and our stock has outperformed the S&P 500 by more than 5,200% over 25 years. At Danaher, you can build a career in a way no other company can duplicate. Our brands allow us to offer dynamic careers across multiple industries. We're innovative, fast-paced, results-oriented, and we win. We need talented people to keep winning. Here you'll learn how DBS is used to shape strategy, focus execution, align our people, and create value for customers and shareholders. Come join our winning team. Danaher is committed to competitive compensation that typically has key components including base salary, variable annual incentive compensation based on personal and company performance, and long-term incentive.
COMPANY SIZE
10,000 employees or more
INDUSTRY
Computer/IT Services
WEBSITE
https://www.danaher.com/