Posted to MedZilla on 8/17/2019

Takeda Pharmaceuticals

US-MN, Quality Assurance Specialist III R0010648-MZ


By clicking the Apply button, I understand that my employment application process with Takeda will commence and that I agree with Takeda s Privacy Notice, Privacy Policy and Terms of Use.

Job Description


  • Perform Quality Assurance activities associated with commercial cGMP biologics drug substance manufactured at the Brooklyn Park site of Takeda.
  • Responsible for review of documentation in support of commercial drug substance manufacturing.
  • Provides guidance to site personnel performing deviation investigations, CAPAs, and change controls through knowledge of quality concepts, investigational techniques, and root cause analysis.
  • Focused primarily on providing support, guidance, and training on complex and non-routine quality-related issues.


  • Performs 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.
  • Develops and provides training on department-specific procedures and systems. Trains and mentors peers.
  • Identifies and proposes Quality Process and system improvements.
  • Participates in internal or supplier audits as needed.
  • Complete mandatory training within required timeframe.
  • Performs additional duties, as assigned, including support of QA Operations, Quality Compliance, and Supplier Quality functions.

Education, Behavioral Competencies and Skills:

  • 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.

Physical Demands:

  • Stand or sit - Must be able to remain in a stationary or standing position for extended periods of time.
  • Wrist and hand motion (e.g. typing, writing)
  • Must be able to work in controlled or clean room environments requiring special gowning.

Other Requirements:

  • May be required to wear personal protective equipment (PPE) and other clean room garments daily. This may include: safety shoes, safety glasses, aprons, face shields, lab coats, full body gowns, hair nets and gloves and hearing protection.
  • May be required to participate in an on-call rotation for off-shift coverage or occasionally work off-shift hours to help support a 24-7 manufacturing department.
  • Willingness to travel to various meetings or training, this could include overnight trips.
  • Requires approximately 5% travel.

Additional Information:

  • Familiarity or experience with the following is preferred: Auditing; basic statistics; Certified Quality Auditor (CQA); Internal / External Auditing; Peer review/approval of documentation; Quality Training; Quality Improvement Tools (Risk Assessments, flowcharts, root cause analysis); Supplier Quality; Technical Writing and Review; Writing/reviewing/approving investigations


Brooklyn Park, MN

Worker Type


Worker Sub-Type


Time Type

Full time

Please visit our website at


* If a direct employer requests that you go to their web site and complete your application there in order to be
  considered, please do so. Applications for all positions are subject to each employer's specific requirements.