Sr. Associate II, Quality Assurance (Quality Operations)

Job Description

About This Role  

This is a full time on-site position

The Sr. Associate II is responsible for the oversight of key strategic, tactical, and operational aspects within Quality Assurance at the Biogen Research Triangle Park (RTP) facility. The Sr. Associate II has an advanced understanding of QC Microbiology laboratory, testing, and Annex I requirements. Additionally, this individual has advanced understanding of the Quality Management Systems and applies that knowledge by coaching peers and ensuring continuous improvement cross-functionally. The Sr. Associate II provides guidance regarding regulatory compliance, technical expertise, independent assessment and expert consultation to Manufacturing, Quality Control, Engineering, Validation, and other supporting departments in a manner consistent with site and corporate policies, cGMP, safety, environmental and human resources policies and procedures. This individual will assist with regulatory and third party audits, aid in the development and implementation of Global Quality Systems, and manage Quality projects and other initiatives.

What You’ll Do  

• Ensure Product Disposition documentation and other documents supporting batch disposition are compliant and determines acceptability for use in cGMP production activities and/or release of product for further processing and /or distribution.
• Serve as a highly skilled technical consultant for quality related issues and assure compliance with regulatory requirements and site procedures. 
• Assess criticality of exceptions/investigations for product impact. Perform thorough reviews of investigations and determine potential areas within the process that may have attributed to the exception. 
• Review documents for compliance and identify gaps in existing quality systems, propose solutions, and drive cross-functional improvement initiatives.
• Collaborate with and/or lead cross-functional teams to execute approved projects aimed at increasing overall quality of business.
• Mentor and train less experienced associates across Quality Assurance functions. Serve as a technical subject matter expert (SME) in support of department functions.
• Additional job duties as assigned.

Qualifications

• Bachelor’s Degree required, preferred in Microbiology or 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
• Must be able to work effectively, both independently and within a team framework across all business areas and levels within the organization locally and globally
• Excellent written, verbal, and interpersonal communication skills required in order to condense complex subjects into key bullet points, articulate recommendations, decisions to Quality Management, develop strong networks cross-functionally to drive collaboration, processes and decisions

Highly Preferred Skills 

• Competencies in QC Microbiology, QC Microbiology laboratory, testing, and Annex I requirements

Additional Information

Why Biogen?

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. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.

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. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about our DE&I efforts.

All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States.