Skip Navigation
Japanese Returning User Login Corporate Website
Menu

Quality Assurance Specialist III

Job ID 1601474 Date posted10/27/2016 LocationBrooklyn Park, Minnesota, United States;
OBJECTIVE:
  • 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.

ACCOUNTABILITIES:
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.
Qualifications

EDUCATION, EXPERIENCE, KNOWLEDGE 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:
  • Wrist and hand motion (e.g. typing, writing)
  • Must be able to work in controlled or clean room environments requiring special gowning
TRAVEL REQUIREMENTS:
  • Willingness to travel to various meetings or client sites, including overnight trips
  • Requires approximately 0-5% travel




we are driven to improve people's lives

www.takedajobs.com

Takeda is an EEO employer of minorities, women, disabled, protected veterans. For more information, visithttp://www.takeda.us/careers/EEO_Policy_Statement.aspx

No Phone Calls or Recruiters Please.

*LI-MJ1-USA


Schedule
Regular 
Full-time