Posted to MedZilla on 6/20/2018


Takeda Pharmaceuticals

US-MN, Quality Assurance Specialist II R0002426-MZ


 
 

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Job Description

Are you looking for a patient-focused company that will inspire you and support your career? If so, be empowered to take charge of your future at Takeda. Join us as a Quality Assurance Specialist II in our Brooklyn Park, Minnesota office.

Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As a QA Specialist II working on the Quality team, you will be empowered to perform document review and work closely with Manufacturing to support GMP compliance.

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 assistance to site personnel performing deviation investigations, CAPAs and change controls.

ACCOUNTABILITIES:

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

This individual:

  • Performs documentation review thoroughly, with a high attention to detail, using 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 in consultation with Supervisor. Makes basic decisions independently. Reviews more complex decisions with management.
  • Identifies and resolves basic technical issues using problem-solving skills, in consultation with Supervisor.
  • Assesses deviations assigned a direct root cause, defined CAPAs, and entry-level change controls.
  • Revises department-specific controlled documents, independently.
  • Receives minimal supervision on routine work assignments. Receives specific instruction on new work.
  • Participates in required training and keeps training files current.
  • Identifies and proposes Quality Process and system improvements.
  • Performs additional duties, as assigned.

EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS:

BA/BS (or Master's) in any Life Science discipline preferred, and/or 3-5 years experience in Regulated (food, medical device, or pharma/biotech) industry.

  • Understands and applies good working knowledge of quality and GMP principles.
  • 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

WHAT TAKEDA CAN OFFER YOU:

  • 401(k) with company match and Annual Retirement Contribution Plan
  • Tuition reimbursement
  • Company match of charitable contributions
  • Health & Wellness programs including onsite flu shots and health screenings
  • Generous time off for vacation and the option to purchase additional vacation days
  • Community Outreach Programs

Empowering Our People to Shine

Learn more at takedajobs.com.

No Phone Calls or Recruiters Please.

#LI-MJ1


Please visit our website at takedajobs.com

 
 


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