Posted to MedZilla on 8/17/2019


Takeda Pharmaceuticals

US-MN, Quality Assurance Specialist III R0010648-MZ


 
 

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Job Description

Objective:

  • 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.

Accountabilities:

  • 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

Locations

Brooklyn Park, MN

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time


Please visit our website at takedajobs.com

 
 


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