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Job Description

About the role:

The QA Supervisor oversees daily quality activities in Teardown/Fractionation, ensuring compliance with FDA, ISO, and company procedures. Responsibilities include batch record review, cGMP compliance, troubleshooting manufacturing issues, and supporting change control processes. They facilitate audits, assess quality risks, and promote Takedas Quality Culture, emphasizing simplicity, accountability, and regulatory compliance.

How you will contribute:

Supervise ongoing daily departmental activities for Quality Assurance, including supervision of personnel.
Partner up with Manufacturing and Engineering for Quality on the Shop Floor collaboration to ensure sound Quality decisions are made with compliance to standards and procedures.
Uphold the Quality systems procedures and Takeda standards per regulations.
Perform or oversee Batch Record Review, Deviation Lifecycle Management (e.g. Deviation records review/approval), Change Control, Floor GEMBAs, and provide Quality representation in meetings such as QWTs, Tier meetings, Fulfillment meetings and other project related initiatives.
Perform quality review and approval regarding product disposition / product impact assessments.
Be directly involved in and where appropriate lead initiatives and project linked to key plant metrics or quality goals.
How you will contribute:
Supervise ongoing daily departmental activities for Quality Assurance, including supervision of personnel.
Partner up with Manufacturing and Engineering for Quality on the Shop Floor collaboration to ensure sound Quality decisions are made with compliance to standards and procedures.
Uphold the Quality systems procedures and Takeda standards per regulations.
Perform or oversee Batch Record Review, Deviation Lifecycle Management (e.g. Deviation records review/approval), Change Control, Floor GEMBAs, and provide Quality representation in meetings such as QWTs, Tier meetings, Fulfillment meetings and other project related initiatives.
Perform quality review and approval regarding product disposition / product impact assessments.
Be directly involved in and where appropriate lead initiatives and project linked to key plant metrics or quality goals.
Perform audit support / preparedness efforts and promote site understanding of regulatory requirements

What you bring to Takeda:

Typically requires bachelors’ degree in science, engineering or other related technical field. 3+ years of related experience. Bachelor’s Degree in Chemistry or Biological Science is preferred..Thorough knowledge of the manufacturing operations, applicable procedures, specifications, regulations and standards.
General knowledge of biopharmaceutical / biotech manufacturing theories and processes.
Result driven with ideas to drive continuous improvement and process simplification with breakthrough solutions.
Have great attention to detail.
Strong analytical and problem-solving skills/critical thinking and problem-solving skills (DMAIC and Lean).

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:
Must be able to lift, push, pull and carry up to 10 lbs.
In general, the position requires a combination of sedentary work and walking around observing conditions in the facility.
Must be able to work in controlled environments requiring special gowning. Will be required to follow gowning requirements and wear protective clothing over the head, face, hands, feet and body.
No make-up, jewelry, contact lenses may be worn in the manufacturing environment.
Will work in a cold, wet environment
Must be able to work multiple shifts, including weekends.
May be required to work in a confined area.
Some Clean Room and cool/hot storage conditions.

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:

USA – CA – Los Angeles

U.S. Base Salary Range:

$84,000.00 – $132,000.00

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 – CA – Los Angeles

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

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Fractionation Quality Assurance Supervisor