About This Role

The Quality Assurance Associate II is responsible for contributing to the oversight of key strategic, tactical, and operational aspects within Quality Assurance at the Biogen Research Triangle Park (RTP) facility. Activities include but are not limited to: review of GMP raw data for compliance, review of GMP documentation to support batch disposition, review/approval of GMP procedures, protocols and reports, GxP Quality systems-related training, identify gaps in existing Quality systems and propose solutions to site management. The QA Associate II will perform all duties in a manner consistent with site and Corporate policies, cGMP, safety, environmental and human resources policies and procedures adhere to all regulatory licenses and regulations, interfacing with key Quality and manufacturing customers, and coordination of investigations impacting the RTP site. The QA Associate II may participate in internal compliance audits; assess and approve discrepancies from site, corporate, and regulatory guidance. The QA Associate II will also support the Supervisor/Manager for activities related to interviewing and training of employees, as well as compliance with training policies.

What You’ll Do

• Review and approval of batch related documentation (cGMP procedures, Master Production Records, Solution Lot records, protocols, and reports) to support product disposition
• Executes activities including; intermediate technical writing, intermediate investigation support (root cause analysis/impact assessment), project representation (moderate complexity)
• Supports resolution of both technical and compliance issues/gaps of moderate complexity. Aides in implementation of Quality Systems/System Improvements with some guidance, moderate technical problem solving (tools or enterprise systems) within function and across multiple functional areas
• Assists Quality Assurance 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
• Control and release of equipment from maintenance, validation, change control and product changeover
• Supports and/or assists in GxP quality systems-related training. Provides some mentorship and training within and across functions

Who You Are

The ideal candidate is curious, eager to learn, asks copious questions and accepts nothing at face value without evidence. Additionally, the candidate has excellent communication/collaboration skills, logical thinking, and can work across all levels of the organization.

Required Skills

• Education: BA/BS in Life Sciences preferred and/or 2-4 years of relevant industry experience
• General understanding of relevant FDA/EMA regulations.
• Plans schedules and arranges own activities when accomplishing objectives.
• Must be able to deal with ambiguity.
• 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.
• General understanding of the cell culture process.
• Excellent oral and written communication skills

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.