Senior Quality Assurance Specialist
4 days ago
We are seeking a highly skilled and experienced Quality Assurance professional to join our team at Biogen. As a Sr. Associate II, Quality Assurance, you will play a critical role in ensuring the quality and compliance of our products.
Key Responsibilities- Ensure product disposition documentation and other relevant documents are compliant with regulatory requirements.
- Provide technical expertise and guidance to Manufacturing, Quality Control, Engineering, Validation, and other supporting departments.
- Assist with regulatory and third-party audits, and aid in the development and implementation of Global Quality Systems.
- Manage Quality projects and initiatives, and drive cross-functional improvement initiatives.
- Mentor and train less experienced associates across Quality Assurance functions.
- Bachelor's Degree in Microbiology or a life science.
- Minimum 5 years of relevant Quality experience.
- Experience working in a pharmaceutical or biotech manufacturing environment.
- Advanced understanding of global quality systems applications, principles, concepts, practices, and standards, and GxP regulations.
- Excellent written, verbal, and interpersonal communication skills.
We are a global team with a commitment to excellence and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact.
Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills.
At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve.
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