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Job Description

About the role:

Perform Quality activities associated with cGMP biologics, intermediate, and/or drug substance manufactured at the Takeda Brooklyn Park Site. Focused primarily on providing support and guidance on complex and non-routine quality-related issues

How you will contribute:

• Follow all established, written procedures. Drive the assessment and implementation of global and local policies, guidance documents, standards, and procedures governing cGMP work performed at the site.
• Performs documentation review thoroughly, with a high attention to detail using extensive working knowledge of quality concepts and internal procedures and controls.
• 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.
• Actively engage with the local team to prioritize and complete activities to support the site goals.
• Review/approve document workflows, low/medium-risk Deviations, CAPAs, and Level 1 and 2 Change Controls.
• Investigate/own quality events (deviations, CAPAs, and Level 1 or 2 Change Controls) for quality-related topics.
• Writes new documents and revises existing documents, independently.
• Develops and provides training on department-specific procedures and systems. Trains and mentors’ peers.
• Contribute to and share best practices in global engagement activities (community of practice) for quality related topics.
• Drive a Continuous Improvement mindset to identify and propose Quality Process and system improvements to meet department/site KPIs.
• Makes informed, >

  Takeda Compensation and Benefits Summary

  We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.

  For Location:

  Brooklyn Park, MN

  U.S. Base Salary Range:

  $89,900.00 - $141,240.00

  
  The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.

  U.S. based employees may be eligible for short-term and/ or long-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.

  EEO Statement

  Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.

  Locations

  Brooklyn Park, MN

  Worker Type

  Employee

  Worker Sub-Type

  Regular

  Time Type

  Full time

  Job Exempt

  Yes