Senior Associate III, Quality Assurance Specialist

2 weeks ago

Denver, North Carolina, United States Biogen Full time
{"title": "Quality Assurance Specialist", "content": "About This Role

The Senior Associate III, Quality Assurance Specialist, is responsible for overseeing key strategic, tactical, and operational aspects within Quality Assurance at the Biogen Research Triangle Park (RTP) facility. This individual provides guidance regarding regulatory compliance, technical expertise, independent assessment, and expert consultation to Manufacturing, Quality Control, Engineering, Validation, and other supporting departments.

Key Responsibilities
  • Ensures 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.
  • Serves as a highly skilled technical consultant for quality-related issues and assures compliance with regulatory requirements and site procedures.
  • Assesses criticality of exceptions/investigations for product impact. Performs thorough reviews of investigations and determines potential areas within the process that may have attributed to the exception.
  • Reviews documents for compliance and identifies gaps in existing quality systems, proposes solutions, and drives cross-functional improvement initiatives.
  • Collaborates with and/or leads cross-functional teams to execute approved projects aimed at increasing overall quality of business.
  • Mentors and trains less experienced associates across Quality Assurance functions. Serves as a technical subject matter expert (SME) in support of department functions.
Requirements
  • Bachelor's Degree in Life Science or other technical discipline.
  • Minimum 7 years directly related to position responsibilities; or Master of Business Administration or Master of Science Degree (MBA/MS) with 5+ years related experience.
  • Expertise in batch disposition of drug substance, including interpretation of specifications for various markets, in a cGMP environment.
  • Excellent written, verbal, and interpersonal communication skills required in order to condense complex subjects into key bullet points, articulate recommendations, decisions to Quality Management, develop strong networks cross-functionally to drive collaboration, processes, and decisions.
  • Knowledge of relevant FDA/EMA regulations and compliance.
  • Strong organizational skills; ability to multi-task and coordinate multiple activities in parallel.
  • Ability to plan, schedule, and arrange own activities when accomplishing objectives in an ambiguous environment.
About Biogen

We are a global team with a commitment to excellence and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established 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 life-changing medicines, with every role playing a vital part in our mission.

", "lang_code": "en-US"}

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