Sr Associate III Quality Assurance Quality Engineering

The schedule for this position is MF Business hours (full time onsite)

About This Role

The Sr. Associate III of Quality Engineering is responsible for understanding quality systems and maintaining oversight of GMP activities while supporting Automation Engineering Facilities Manufacturing and Quality Assurance/Quality Control stakeholders at the Biogen Research Triangle Park (RTP) Pharma facility. They should be proficient in their understanding of the quality systems and apply that knowledge in coaching and continuous improvement cross functionally and globally. Additionally the Sr. Associate III will ensure oversight and completion of all departmental milestones associated with clinical and commercial product manufacture. 

What Youll Do  

• Assist in the development and implementation of Global Quality Systems leading site and global initiatives provide oversight with respect to the proper administration and adherence to all Biogen policies and procedures as well as regulatory licenses and regulations and interfacing with key Engineering Manufacturing and Quality customers
• Review of GMP raw data for compliance review and approval of GMP documentation (including CAPAs change controls drawings exceptions procedures records shutdown documentation validation protocols work orders etc.) and identify gaps in existing quality systems and propose solutions to site management
• Support oversight of quality systems and GMP activities as well as site performance monitoring systems such as Quality Council Site Management Review Site Governance Boards (e.g. CAPA Review Board Change Control Review Board Deviation Review Board) 
• Proactive identification and resolution of both technical and compliance issues/gaps. Develop and implement aspects of various Quality Systems/System Improvements
• Support site capital projects by providing GMP guidance risk management input and quality oversight during shutdown planning release and other major equipment/facility improvements 
• May support internal and external inspections assess and approve discrepancies from site corporate and regulatory guidance. In addition support the manager for activities related to training of employees as well as compliance with training policies
• Additional duties as assigned

Qualifications :

Required Skills  

• Bachelors Degree in engineering or related life sciences field
• Minimum 710 years of experience working in Quality in a biotech/pharmaceutical GMP environment
• Expertise with Change Control Exceptions Management and Record Issuance
• Thorough knowledge of current global Regulatory Quality requirements
• Knowledge of industry practices in Engineering Quality Control Quality Systems and Validation 
• Regulatory Agency inspection experience
• Robust knowledge of labeling/packaging operations and validation 

Additional Information :

Why Biogen

We are a global team with a commitment to excellence and a pioneering spirit. As a midsized biotechnology company we provide the stability and resources of a wellestablished 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 lifechanging 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 EVerify Employer in the United States.