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Job Description

About the role:

The Quality Associate II - Deviation and CAPA is in the Quality Systems organization at the Takeda Round Lake aseptic pharmaceutical manufacturing facility. Your primary responsibility will be to serve as the administrator for the electronic deviation and CAPA system and for the deviation and CAPA process. Your secondary responsibilities will be to support other quality system processes including change control management, document control, and validations. You will support projects aimed at improving deviation and CAPA management processes at the Round Lake facility, including launches of and changes to electronic systems. This support may include computer system validation activities (e.g., execution of test cases) or training of users. You will report to the Manager of Quality Disposition.

How you will contribute:

• Owns Standard Operating Procedures and other Quality System Documentation relevant to their responsibilities/expertise. Monitor activities/prepares metrics related to responsibilities/expertise and escalates issues and appropriate. Collaborate with cross-functional personnel to improve Quality System processes. Approve SOPs/documents of responsibilities/expertise.
• Develop, approves, and delivers training materials relevant to their area of expertise.
• Assist personnel with validation-related documentation, as assigned.
• Assist personnel with document control related activities, as assigned.
• Manage investigations and CAPAs and approve investigations and CAPAs important to all areas of the plant.
• Manage and approve change controls important to all areas of the plant.
• Lead Quality project teams and presents project plans, progress, and risks to plant management.
• Represent us in areas of expertise to governmental regulatory bodies
• Identify, escalate, and resolve potential compliance and safety issues.

What you bring to Takeda:

• Typically Requires: Bachelors' degree in science, engineering or other related technical field and 2+ years of related experience
• Must be proficient in written and oral English.
• Experience applying cGMPs.
• Will work as a collaborative team member and in some cases lead a small team.
• Experience presenting to inspection auditors.
• Experience in use of electronic systems such as TrackWise.

• In general, your work will be a combination of sedentary work and walking around observing conditions of the facility.

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. You may:

• May 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.
• Need to remove all make-up, jewelry, contact lenses, nail polish and artificial fingernails while in the manufacturing environment.
• Must be able to stand and/or walk for an extended period over an 8-12 hour shift between rooms and across the site.
• Indoor working conditions.
• Will work around moving equipment and machinery.
• Work in a cold, wet environment.
• Work multiple shifts, including weekends, or be asked to work supplemental hours.
• Work around chemicals such as alcohol, acids, buffers and Celite that may require respiratory protection.

More about us:

At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and the best patient support programs. Takeda is a patient-focused company to 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

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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