Job Description

This is a full time, on site position with M-F business hours

About This Role   

Sr. Associate I is responsible for contributing to key strategic, tactical, and operational aspects within Quality Assurance at the Biogen Research Triangle Park (RTP) Drug Product Parenteral facility.  Specifically, this role will have primary quality oversight of the following activities: (1) Batch Records, (2) Exceptions/Investigations and (3) QA Controlled Documentation.  It is expected that this role will report directly into a Sr. Manager.   

What You’ll Do   

• Product Disposition:  Reviews documents (e.g., production records, test methods, raw data, and certificates of analysis) for compliance and determines acceptability for use in GMP production activities and/or release of product for further processing and/or distribution.
• Exceptions, Complaints and CAPA:  Assesses criticality of exceptions/investigations for product impact.  Performs thorough reviews of the investigations and provides feedback to the department owner.  Supports complaint investigations with the ability to analyze the complaint defect and determine potential areas within the process that may have attributed to the defect.  Collaborates with associated departments to determine the appropriate  
• QA Controlled Documentation: Review and approve content for controlled documents within the quality system to ensure compliance with procedural requirements and standards. Additionally, technical reports issued requiring a Quality review are in scope of this role.   

Who You Are   

Looking for someone who is task driven and focused; taking action to resolve, remediate and/or improve.  Collaborative person capable of being both agile and customer focused. 

Qualifications

Required Skills   

• Bachelor’s degree required, preferred in a science discipline
• Minimum 4 years of experience working in a GMP quality environment within biotech/pharmaceutical industry
• Experience in drug product batch record review and disposition  
• Experience with deviations varying in complexity  
• Strong knowledge in FDA/EMA regulations and compliance   
• Strong organizational skills; ability to multi-task 
• Investigative mindset and solid decision making skills  
• Critical thinking skills and has a questioning attitude 

Preferred Skills  

• Experience in aseptic fill/finish manufacturing operation 
• Microbiology experience
• Experience working in a parenteral filling environment
• Experience supporting audits and/or investigations

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.