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Job Description

About the role:

The QA Specialist II oversees daily activities within Quality Assurance Operations. You will work as part of aa team, providing quality leadership and ensuring product quality and compliance. Main 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. You will uphold Takeda’s Quality Culture elements of keeping it simple, taking pride in doing it right, ensuring a speak up culture and overseeing and demonstrating commitment to Quality.

How you will contribute:

Oversee and approve Standard Operating Procedures (SOPs) and other quality documentation relevant to the Quality department and all areas of the plant.
Develop, delivers, and approves training materials related to Quality operations, ensuring agreement across all plant areas.
Manage a QA Operations team, encouraging continuous development and ensuring the achievement of performance goals. Provide leadership and oversight to quality operations and other responsibilities and escalate.
Manage investigations and CAPAs for the Quality department, providing oversight and approvals for compliance across all plant operations.
Oversee and approve change controls within the Quality department, ensuring understanding of existing compliance requirements.
Provide Quality approval for labeling artwork and packaging material specifications using artwork management software.
Lead Quality project teams, presenting project plans, progress, and risks to plant management, and representing the organization to regulatory bodies.
Approve documentation following cGMP guidelines, identifying opportunities for process improvements and ensuring compliance on the manufacturing floor.
Review and approve raw materials following 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.
Be a subject matter expert (SME) during internal and external regulatory audits, presenting Quality operations to auditors.
Collaborate with Manufacturing and Engineering teams through Quality on the Shop Floor (QOTSF) programs to lead sound, compliant Quality decisions.
Conduct gap assessments and implement global processes to enhance Quality operations.
Manage Final Container sampling processes and Quarantine and Reject processes for materials and finished products.
Experience with visual inspection and AQL processes related to parenteral drugs.
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).

What you bring to Takeda:

Bachelor's degree 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. You may:

You will be asked to 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 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 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.
Can work non-traditional work hours or work extended hours, including weekends and holidays.

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.

For Location:

USA - IL - Round Lake - Drug Delivery

U.S. Base Salary Range:

$108,500.00 - $170,500.00

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-termincentives. 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.

Locations

USA - IL - Round Lake - Drug Delivery

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

Job Exempt

Yes

Learn more about this Employer on their Career Site

Sr Quality Assurance Specialist II - QA Ops