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Quality Assurance Specialist II - 2nd Shift

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 Assurance Specialist II - 2nd Shift

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Job ID R0020809 Date posted 07/01/2020 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 Assurance Specialist II (2nd Shift) in our Brooklyn Park office.

At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

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

As a Quality Assurance Specialist II (2nd Shift) working on the team, you will be empowered to help increase quality and service to both internal and external clients. In this role, you will contribute to Takeda’s mission by helping to build a better tomorrow for our patients and their families. A typical day will include:

SHIFT: Thursday - Monday 2nd shift

POSITION OBJECTIVES:

  • Perform Quality Assurance activities associated with commercial cGMP biologics drug substance manufactured at the Brooklyn Park site of Takeda.
  • Responsible for review of batch records and associated documentation in support of timely commercial drug substance batch disposition.
  • Provides assistance to site personnel performing deviation investigations, CAPAs, and change controls.
  • Focused primarily on providing support and guidance on non-complex and routine quality-related issues.

POSITION ACCOUNTABILITIES:

  • 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.
  • Administrates QA Operations systems in support of GMP manufacturing activities; material hold, equipment out of service, etc.
  • Identifies and resolves basic technical issues using problem-solving skills, in consultation with management.
  • Supports deviations assigned a direct root cause, defined CAPAs, and entry-level change controls.
  • Revises and reviews department-specific controlled documents independently.
  • Receives minimal supervision on routine work assignments. Receives specific instruction on new assignments.
  • Identifies and proposes Quality Process and system improvements.
  • Complete mandatory training within required timeframe.
  • Performs additional duties, as assigned, including support of QA Compliance Review, Quality Compliance, and Supplier Quality functions.

EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS:

  • BA/BS (or Master's) in any Life Science discipline preferred, and/or at least 2+ 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 REQUIREMENTS:

  • 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.

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

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Locations

Brooklyn Park, MN

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

Job ID R0020809

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