About This Role  This is a full time on-site positionThe Sr. Associate II is responsible for the oversight of key strategic, tactical, and operational aspects within Quality Assurance at the Biogen Research Triangle Park (RTP) facility.  The Sr. Associate II has an advanced understanding of QC Microbiology laboratory, testing, and Annex I requirements.  Additionally, this individual has advanced understanding of the Quality Management Systems and applies that knowledge by coaching peers and ensuring continuous improvement cross-functionally. The Sr. Associate II provides guidance regarding regulatory compliance, technical expertise, independent assessment and expert consultation to Manufacturing, Quality Control, Engineering, Validation, and other supporting departments in a manner consistent with site and corporate policies, cGMP, safety, environmental and human resources policies and procedures. This individual will assist with regulatory and third party audits, aid in the development and implementation of Global Quality Systems, and manage Quality projects and other initiatives. What You’ll Do  Ensure Product Disposition documentation and other documents supporting batch disposition are compliant and determines acceptability for use in cGMP production activities and/or release of product for further processing and /or distribution.   Serve as a highly skilled technical consultant for quality related issues and assure compliance with regulatory requirements and site procedures. Assess criticality of exceptions/investigations for product impact. Perform thorough reviews of investigations and determine potential areas within the process that may have attributed to the exception. Review documents for compliance and identify gaps in existing quality systems, propose solutions, and drive cross-functional improvement initiatives.  Collaborate with and/or lead cross-functional teams to execute approved projects aimed at increasing overall quality of business.  Mentor and train less experienced associates across Quality Assurance functions. Serve as a technical subject matter expert (SME) in support of department functions.Additional job duties as assigned.
