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Quality Assurance Specialist III

Job ID 1601474 Date posted02/23/2017 LocationBrooklyn Park, Minnesota, United States;
  • This individual will perform Quality Assurance activities associated with commercial cGMP biologics drug substance manufacture at the Brooklyn Park site of Takeda.
  • This person is responsible for review of batch records and associated documentation in support of timely commercial drug substance batch disposition.
  • This person provides guidance to site personnel performing deviation investigations, CAPAs and change controls through knowledge of quality concepts, investigational techniques and root cause analysis.

This position is focused primarily on providing support, guidance, and training on complex and non-routine quality-related issues. 

This individual:
  • Performs batch and supporting documentation review thoroughly, with a high attention to detail, using extensive working knowledge of quality concepts and internal procedures and controls.
  • Supports GMP compliance with time spent in the Manufacturing environment on a regular basis.
  • Analyzes and interprets projects, studies, or investigations to determine next steps. Makes decisions independently and notifies management of action taken.
  • Identifies, investigates, and resolves complex technical issues using problem-solving skills. Notifies management of actions taken.
  • Reviews deviations, investigations, and CAPAs associated with cGMP compliance. Supports change controls related to Quality topics.
  • Writes new documents and revises existing  documents, independently.
  • Performs QA review/approval of controlled documents.
  • Receives minimal supervision on work assignments. Receives overall project direction from management, but completes most work independently.
  • Participates in required training and keeps training files current.
  • Develops and provides training on department-specific procedures and systems.
  • Identifies and proposes Quality Process and system improvements.
  • Participates in internal or supplier audits as needed.
  • Performs additional duties, as assigned.


BA/BS (or Master's) in any Life Science discipline preferred, and/or 5+ years experience in Regulated (food, medical device, or pharma/biotech) industry. 
  • Must have direct experience with Quality Assurance within the Life Science industry.
  • Understands and applies comprehensive knowledge of quality and GMP principles. Maintains current understanding of global GMP regulations.
  • Ability to handle multiple tasks concurrently and in a timely fashion. 
  • Good interpersonal skills and ability to work effectively and efficiently in a team environment to accomplish goals.
  • Excellent verbal and written communication skills and ability to communicate effectively with site personnel, peers and management.
  • Must be able to read, write and converse in English.
  • Must display eagerness to learn and continuously improve.
  • Positive work attitude that supports teamwork and continuous improvement.
  • Must have the following personal attributes:  integrity and trust, work ethic, sound judgment, intellectual honesty, pragmatism, courage and conviction.
  • Must be experienced in Microsoft Office applications, especially Word, Excel and PowerPoint. 
  • Wrist and hand motion (e.g. typing, writing)
  • Must be able to work in controlled or clean room environments requiring special gowning
  • Willingness to travel to various meetings or client sites, including overnight trips
  • Requires approximately 0-5% travel

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