Job Description

This position will work from 6 AM to 6 PM on a 2,2,3 rotation schedule

The Senior Quality 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) Shop floor support ensuring critical steps are executed according to batch record and procedural requirements, (2) Exceptions review and approval and (3) Respond to operational needs that require QA approval, all within our parenteral filling area.

What You’ll Do  

• Ensures product documentation and other documents supporting batch execution are compliant and determines acceptability for use in cGMP production activities and/or release of product for further processing and/or distribution.
• Drives exceptions to closure and ensures compliance with procedures and process including thorough documented root cause analysis and well justified rational supports the stated conclusions. 
• Actively monitors the applicable data dashboards and collaborates with stakeholders to improve process effectiveness and efficiency.
• Supports Quality Management and Operations staff in the coordination of, preparation for and follow up of internal/external audits and inspections as required.
• Assists QA Management in additional responsibilities related to the day-to-day implementation of the Quality Management Systems required to maintain cGMP compliance, and ensure the safety, efficacy and purity of the products manufactured by Biogen.
• Supports and/or assists in GxP quality systems-related training. Provides some mentorship and training within and across functions.

Who You Are  

You are task oriented and focused on continuous improvement. You ask copious questions and excel at root/cause analysis and troubleshooting. Additionally, you have excellent communication/collaboration skills, logical thinking, and can work across all levels of the organization.

Qualifications

• Bachelor’s degree required, preferably in a field of science or biotechnology, or related.
• A minimum of 4 years relevant technical experience in quality oversight, preferably in a biotech or pharmaceutical manufacturing operation.
• General understanding of relevant FDA/EMA regulations and compliance.
• Strong organizational skills.
• General understanding of Quality concepts; able to practice and implement them.
• Ability to develop innovative/creative solutions to issues of moderate complexity.
• Detail oriented aptitude.
• Excellent oral and written communication skills.

Preferred Skills 

• Parenteral filling experience strongly desired.

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.