Sr. I Associate, Quality Assurance

Job Description

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 and (3) Partner Program support. It is expected that this role will report directly into a Sr. Manager.

• 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 course of action.
• Partner Program support: Liaison with Partner QA ensuring timely communication of investigations, production issues, complaints, and various other requests.

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

• Bachelor’s degree strongly preferred
• Minimally 5 yrs. relevant technical experience
• Experience in drug product batch record review and disposition
• Experience with deviations varying in complexity as both an author and approver
• Strong knowledge in FDA/EMA regulations and compliance
• Strong organizational skills; multi-task
• Investigative mindset and solid decision making skills

• Experience in aseptic fill/finish manufacturing operation

Additional Information

Our mission to find therapies for neurological and rare diseases is a unique focus within our industry and this shared purpose is what connects usasa 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.