Position will work 4 days, 10-hour shift: Fri – Mon from 7:30 AM to 6 PM

Sr. Associate I, Quality Assurance is responsible for contributing to key strategic, tactical, and operational aspects within Quality Assurance (QA) at the Biogen Pharma 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) Exception’s review and approval and (3) Respond to operational needs that require QA approval. As appropriate, the Sr. Associate may also recommend changes to existing quality systems and GMP processes (change control), identify gaps in existing quality systems, propose solutions to QA management.

What You’ll Do:

1. Ensure Product documentation and other documents supporting batch execution are compliant and determine acceptability for use in cGMP production activities and/or release of product for further processing and/or distribution.
2. Drive Exceptions to closure and ensure compliance with procedures and process including thorough documented root cause analysis and well justified rational supports the stated conclusions. 
3. Actively monitor the applicable data dashboards and collaborate with stakeholders to improve process effectiveness and efficiency.  
4. Interact with peers in all departments/sites with the purpose of coordination of disposition activities, investigations, discussions pertaining to strategic initiatives and compliance-related issues.
5. Support Quality Management and Operations staff in the coordination of, preparation for and follow up of internal/external audits and inspections as required.
6. Assist 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.

Who You Are:

You are quality minded, ask directed questions, and challenge assumptions. You are an excellent communicator and thrive collaborating with other teams. You are task oriented and focused on continuous improvement.

• Bachelor’s degree, preferably in a field of science or biotechnology.
• 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.
• General understanding of the manufacturing process.
• 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 Qualifications

Experience in Oral Solid Dosage and/or Aseptic Manufacturing and in a Quality role.

Why Biogen?

Our mission to find therapies for neurological and rare diseases is a unique focus within our industry and this shared purpose is what connects us as a team. We work together to overcome obstacles and to follow the science. We are resilient as we strive to make an impact on our patients’ lives and on changing the course of medicine. Together, we pioneer. Together, we thrive.

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.