By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’sPrivacy Noticeand Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.

Job Description

About the role:

The Quality Operations Supervisor is responsible for oversight of the day-to-day activities related to the Quality Assurance Operations team. The incumbent will work as part of a cross-functional teams providing quality leadership and focus on product quality and compliance through Quality on the shop floor (QOTSF), Acceptable Quality Limit (AQL) inspection, Incoming raw materials release, Documentation review (Batch records, electronic batch records, etc.), Investigation approvals and Quality oversight of manufacturing processes.

How you will contribute:

• Supervises a team of Quality Technicians and Quality Analysts.  Responsible for the team’s continuous development and ensuring they are meeting performance objectives. 

• Owns Standard Operating Procedures and other Quality Documentation relevant to Quality department. Approves Standard Operating Procedures and other Quality Documentation pertinent to all areas of the plant.

• Develops and delivers training materials relevant to Quality operations. Approves training materials pertinent to all areas of the plant.

• Owns investigations and CAPAs relevant to quality department. Approves investigations and CAPAs pertinent to all areas of the plant.

• Approves change controls for compliance to existing requirements.

• Quality Approval of labeling artwork and specifications for packaging material using appropriate artwork management software.

• Leads Quality project teams and presents to plant management project plans, progress, and risks. Represents the organization to governmental regulatory bodies.

• Review and approve appropriate documents following cGMP guidelines and suggest continuous improvement ideas for better processes. Review manufacturing processes for cGMP compliance on the floor.

• Review and approve raw materials according to standard operating procedures and release them for manufacturing use. Resolve issues related to materials release.

• Participate in internal and external regulatory audits as a SME for Quality operations and present to auditor, if required.

• Responsible for AQL and QOTSF programs trending, and escalation as required for Round Lake site and present appropriate data to Quality Council.

• Experience with visual inspection and AQL processes related to parenteral drugs is preferred.

• Knowledge of manufacturing processes related to aseptic filling, visual inspection, and packaging.

• Must have knowledge of FDA Regulations and Application of Good Manufacturing Practice.

• Must demonstrate strong leadership, influence, and cross-functional collaboration skills and able to work efficiently in a cross-functional team environment.

• Ability to prioritize and thrive in a fast-paced environment.

• Strong interpersonal skills and attention to detail.

• Must be a team player with excellent problem-solving, critical thinking, and decision-making skills.

• Highly effective verbal and written communication skills.

• Must be able to manage multiple projects concurrently.

• Excellent Microsoft Office skills (Word, Excel, Project, and PowerPoint).

What you bring to Takeda:

• Typically requires bachelor's degree, preferably in science, engineering, or other related technical field. 

• 4+ years of related work experience.

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:

• The candidate must not be allergic to Cephalosporin drugs.

• Ability to walk 1-3 miles and lift 10 lbs. during a workday is required.

• Indoor working conditions.

• May work around moving equipment and machinery.

• Some Clean Room and/or cool/hot storage conditions.

• 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.

• Will need to remove all make-up, jewelry, contact lenses, nail polish and/or artificial fingernails while in the manufacturing environment.

• May work in a cold, hot or wet environment.

• May work around chemicals such as alcohol, acids, buffers and Celite that may require respiratory protection.

• Must be able to work aligned shift.

• Must be able to work non-traditional work hours or work extended hours, including weekends and holidays, as needed. 

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

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:

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

Worker Type

Worker Sub-Type

Time Type

Job Exempt