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Job Description

About the role:

The QA Specialist II is responsible for overseeing day-to-day activities within Quality Assurance Operations. This role works as part of cross-functional teams, providing quality leadership and ensuring product quality and compliance. Key responsibilities include Quality on the Shop Floor (QOTSF), Acceptable Quality Limit (AQL) inspections, incoming raw material release, documentation review (e.g., batch records and electronic batch records), and approvals for investigations and change controls. The incumbent will uphold Takeda’s Quality Culture elements of keeping it simple, taking pride in doing it right, ensuring a speak up culture and owning and demonstrating commitment to Quality.

How you will contribute:

• Owns and approves Standard Operating Procedures (SOPs) and other quality documentation relevant to the Quality department and all areas of the plant.

• Develops, delivers, and approves training materials related to Quality operations, ensuring alignment across all plant areas.

• Lead and manage a QA Operations team, fostering continuous development and ensuring the achievement of performance objectives. Provide leadership and oversight to quality operations and other functions and escalate if required.

• Manages investigations and CAPAs for the Quality department, providing oversight and approvals for compliance across all plant operations.

• Owns and approves change controls within the Quality department, ensuring alignment with existing compliance requirements.

• Provides Quality approval for labeling artwork and packaging material specifications using artwork management software.

• Leads Quality project teams, presenting project plans, progress, and risks to plant management, and representing the organization to regulatory bodies.

• Reviews and approves documentation following cGMP guidelines, identifying opportunities for process improvements and ensuring compliance on the manufacturing floor.

• Reviews and approves raw materials in accordance with SOPs, releasing materials for manufacturing use, resolving issues related to materials release, and overseeing preprinted material accountability, material receipt, and JDE inventory management system issues.

• Acts as a subject matter expert (SME) during internal and external regulatory audits, presenting Quality operations to auditors as needed.

• Collaborates with Manufacturing and Engineering teams through Quality on the Shop Floor (QOTSF) initiatives to drive sound, compliant Quality decisions.

• Conducts gap assessments and implements global processes to enhance Quality operations.

• Manages Final Container sampling processes as well as Quarantine and Reject processes for materials and finished products.

• 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.

• Knowledge of FDA, EMA, CFDA, PDA Regulations, application of Good Data and Documentation Practices (GDDP) and application of current Good Manufacturing Practices (cGMP).

• Must demonstrate a strong ability to contribute, influence, and collaborate across functions, working effectively and 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:

• Bachelor's degree, preferably in science, engineering, or other related technical field. 

• 6+ 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.

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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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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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