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Quality Systems Specialist II

Brooklyn Park, Minnesota

Overview

Every day, employees working in Takeda’s Global Manufacturing and Supply Chain, and Global Quality business unit are shaping the future of healthcare. They are breaking down barriers and ensuring our life-changing medicines are available, accessible, and affordable to patients. Life-changing for you. Life-changing for patients.

Global Manufacturing and Supply Chain, and Global Quality is the backbone of Takeda, and our employees are the guardians for our patients, our products, and our reputation. As a member of our team, we can offer you the opportunity to grow in a meaningful career, develop your skills, and come to work every day knowing that what you do makes a genuine difference.

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Success

What makes a successful member of our team? Check out the traits we’re looking for and see if you have the right mix.

  • Agile
  • Ambitious
  • Analytical
  • Collaborative
  • Enthusiastic
  • Entrepreneurial

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Opportunity

  • Bold initiatives, continuous improvement, and creativity are at the heart of how we bring scientific breakthroughs from the lab to patients.

  • Here, you will feel welcomed, respected, and valued as a vital contributor our global team.

  • Through trust and respect, you will have genuine support from leaders, managers, and colleagues to do your best work.

  • A strong, borderless team, we strive together towards our priorities and inspiring mission.

  • Recognized for our culture and way of working, we’re one of only 13 companies to receive Top Global Employer® status for 2020.

  • Our people-first mission extends beyond patients to include their families, communities, and our own Takeda family.

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Quality Systems Specialist II

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Job ID R0022655 Date posted 09/07/2020 Location Brooklyn Park, Minnesota

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Job Description

Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as a Quality Systems Specialist IIin our Brooklyn Park, MN office.

Here, you will be a vital contributor to our inspiring, bold mission.

As a Quality Systems Specialist IIworking on the Quality team, A typical day will include:

OBJECTIVE:

  • Serve as the primary Business Administrator and subject matter expert (SME) for Takeda's Electronic Quality Management System (EQMS) and other applications, as they arise.
  • Support quality management procedures and provide targeted technical training (e.g., deviation,CAPA, change management).
  • Support other Quality Systems areas as needed.

ACCOUNTABILITIES:

  • This position is responsible for routine monitoring, reporting and escalation of quality performance metrics according to established controlled procedures.
  • Provide routine Business Administration support for the Brooklyn Park EQMS (e.g., processing of applicable Help Desk Tickets, Administration of user accounts and EQMS user roles, etc.).
  • Routinely monitors the EQMS for compliance with procedures, and completion of deliverables according to committed timelines. Track progress against baseline metrics.
  • Completes work thoroughly, with a high attention to detail, using working knowledge of quality concepts and internal procedures and controls.
  • 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 (0-2 with Master's) 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:

  • 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.

Locations

Brooklyn Park, MN

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

Job ID R0022655

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