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Job Description

About the Role:

The Quality Operations, Analyst II is responsible for ensuring the quality of processes and product outputs by adhering to established policies and procedures. This role involves auditing, monitoring, and determining the quality of processes or outputs against defined internal and regulatory standards, contributing to Takeda's mission of delivering high-quality products.

How you will contribute:

• Leads ongoing, daily departmental operations. 

• May include the supervision of assigned personnel in achieving defined quality goals in an efficient, accurate and timely manner

• Interview/hire, evaluate, train and develop direct reports

• Perform in-depth internal assessments and evaluations by collecting and analyzing accurate, objective evidence regarding risks and their magnitude.  Assessments and information gathering may be through in-depth employee interviews, flow charting and other informational gathering techniques.  Determine the logic, adequacy and effectiveness of processes, systems and related requirements.  Develop plans to correct identified risks including areas of non-conformance, inform management and implement approved corrective action plans.  

• Provide quality oversight for packaging operations, including control of printed materials, visual inspections, verification of labels and product packaging, perform AQL inspections, Batch Record review- meeting requirements of CFR 21.

• Support Customer Complaint investigations with inspection of retention samples and returned product.

• Write, review, analyze and revise written Standard Operating Procedures (SOPs) and submit procedural changes as needed to meet Corporate, Divisional, Plant, Regulatory Requirements, etc.

• Support external assessments or audits.

• Assist with audits of various reports (Protocols, Qualifications, Regulatory Submissions, etc.)

• Serve as Subject Matter Expert (SME) and provide training to local employees as needed on packaging compliance

• Other duties, tasks, or projects as assigned

What you bring to Takeda:

• Associate's degree in business/scientific discipline and one to three years of relevant experience.

• Bachelor’s degree in the life sciences and experience with a medical device/pharma or other similarly regulated industry preferred

• Experience with packaging operations in biopharmaceutical industry preferred

• 20/20 eye sight (corrective lenses OK), no color blindness, attention to detail, and must be able to perform visual inspection of large parenteral vials. Hiring is dependent on the ability to pass visual exam and visual inspection qualification.

• Strong interpersonal skills and great attention to detail are necessary. Must be able to influence decisions based on regulatory knowledge, and must have excellent problem solving, as well as verbal and written communication skills.

• Must have the ability to manage people, encourage teamwork and drive actions based on strategy. The position will include the supervision of assigned personnel on multiple shifts in achieving defined quality goals in an efficient, accurate and timely manner.

• Must have ability to evaluate, train, and develop direct reports. 

• Must have adequate computer experience (knowledge of Microsoft Word, Excel and PowerPoint, TrackWise, Delta V, MES Systems)

• Must have knowledge of FDA Regulations, Applications of Good Laboratory Practices, and Application of Good Manufacturing Practices.

• Must demonstrate excellent critical thinking skills and understanding of complex manufacturing processes and make risk based Quality Decisions on deviations based on knowledge of regulations and regulatory trends.

• Must be able to make risk based Quality Decisions on deviations based on knowledge of regulations and regulatory trends.

• Must understand CFR requirements in regards to packaging, label controls, and visual inspection.

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, and buffers and Celite that may require respiratory protection.

• Combination of sedentary work and walking around observing conditions in the facility.

• Able to lift, push, pull and carry up to 25 lbs.

• May require on call support.

• 20/20 vision (with corrective lenses), no color blindness, depth perception, and be able to perform repetitive motions required for vial inspection.

• Must be able to work swing shift, some weekends, and holidays to support manufacturing.

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.

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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.

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U.S. Base Salary Range:

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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