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Job Description

About the role:

As a Deviation Investigator - Quality Control, you will perform deviation investigations, CAPAs, and change controls through knowledge of quality concepts, investigational techniques, and root cause analysis. You will be responsible for routine monitoring, reporting and escalation of quality performance metrics according to established controlled procedures.

How you will contribute:

• Operate Brooklyn Park EQMS (e.g., processing of applicable Help Desk Tickets, Administration of user accounts and EQMS user roles).
• Monitor the EQMS for compliance with procedures, and completion of deliverables according to committed timelines. Track progress against baseline metrics.
• Lead Global EQMS projects related to EQMS topics (e.g., Community of Practice, workstream participation)
• Review and write deviations, investigations, change controls and CAPAs associated with cGMP compliance.
• Review and approve deviations for compliance to IQS standards.
• Identify, investigate, and resolve complex technical issues using problem-solving skills.
• Analyze and interpret projects, studies, or investigations to determine next steps.
• Write and revise documents independently.
• Perform QA review/approval of controlled documents ie. Veeva workflows.
• Participate in internal or supplier audits.
• Develop and provide training on department-specific procedures and systems ie. Deviations, IQS.
• Participate in required training and keep training files current.
• Identify, propose, and implement Quality Process and system improvements.
• Help implement global QA approaches based on sound principles, international industry/regulatory standards, and scientific basis.
• Assist in troubleshooting issues related to quality concerns, implementing solutions and corrective actions

What you bring to Takeda:

• BA/BS required. Life Science discipline would be ideal.
• 5+ years' experience in Regulated (food, medical device, or pharma/biotech) industry preferred.
• Direct experience with Quality Assurance within the Life Science industry strongly desired.
• Understand and apply comprehensive knowledge of quality and GMP principles. Maintain current understanding of global GMP regulations.
• Previous experience with the following would be ideal. This includes Auditing, basic statistics, and Peer review/approval of documentation. Experience with Quality Training, Quality Improvement Tools, and Supplier Quality is desired. Technical Writing and Review, and Writing/reviewing/approving investigations, are also valuable.
• Must be experienced in Microsoft Office applications, especially Word, Excel, and PowerPoint.

Important Considerations:

At Takeda, our patients rely on us to deliver quality products. As a result, we must follow strict rules in our manufacturing facilities to ensure we are not endangering the quality of the product. In this role, you may:

• Work in a controlled environment requiring special gowning and wear protective clothing over the head, face, hands, feet and body. This may include additional hearing protection for loud areas.
• Need to remove all make-up, jewelry, contact lenses, nail polish and/or artificial fingernails while in the manufacturing environment.
• Work in a cold, wet environment.
• Work multiple shifts, including weekends, or be asked to work supplemental hours, as necessary.
• Work around chemicals such as alcohol, acids, buffers and Celite that may require respiratory protection.
• Stand or sit -> Must be able to remain in a stationary or standing position for extended periods of time.
• In general, the position requires mostly sedentary work with occasionally walking throughout the facility.
• Wrist and hand motion (e.g., typing, writing) while operating office equipment such as computer, phone, calculator, etc.
• Willingness to travel to various meetings or client sites, including overnight trips.
• Requires approximately 0-5% travel.

More about us:

At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.

Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

#GMSGQ #ZR1 #LI-MA1

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:

U.S. Base Salary Range:

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.

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Job Exempt