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Senior Quality Assurance Specialist

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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Senior Quality Assurance Specialist

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Job ID R0020812 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 Sr Quality Assurance Specialist 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 Sr Quality Assurance Specialist 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:

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 expertise and guidance in interpreting governmental regulations, agency guidelines and internal policies related to quality assurance operations, and may support and/or represent the Quality Assurance functional area as a subject matter expert (SME) during regulatory and third-party inspections.
  • Focused primarily on providing support, guidance, and training on complex and non-routine quality-related issues.

ACCOUNTABILITIES: 

  • 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.
  • Leads investigation teams and ensures proper close out and follow up.
  • Reviews/approves deviations, investigations, and CAPAs associated with cGMP compliance. Initiates, monitors, and reviews/approves change controls related to Quality topics.
  • Represent QA on cross-functional project teams such as tech transfer, process validation, and process improvements.
  • 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/systems and quality-related topics from industry. Trains and mentors peers.
  • Identifies, proposes, and implements 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 Compliance and Supplier Quality functions.

EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS:

  • BA/BS (or Master's) in any Life Science discipline preferred, and/or 8+ 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.
  • Familiarity or experience with the following is preferred: Auditing; basic statistics; 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
  • 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 be experienced in Microsoft Office applications, especially Word, Excel and PowerPoint.

LICENSES/CERTIFICATIONS:

  • Certified Quality Auditor (CQA) a plus

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.

Locations

Brooklyn Park, MN

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

Job ID R0020812

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