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Job Description

ob Title: Quality Analyst

Location: Thousand Oaks, CA

About the role:

You will perform the daily quality operations for Formulation & Filling, Final Packaging and device assembly processes. This is an on-site role and you will report to the Supervisor, Quality Drug Product.

How you will contribute:

• Conduct QA Inspection activities associated with visual inspection, formulation/filling, assembly, packaging, and label stores management.

• Perform the final review of QA Inspection documentation to support Filled Unlabeled Vial (FUV) and Final Drug Product (FDP) release.

• Identify and assess quality risks in activities and processes according to regulatory agency requirements and guidelines and Takeda quality practices.

• Revise documents to drive continuous improvement by streamlining processes, maintaining GMP compliance, support process improvements, corrective actions, corporate compliance, and audit commitments.

• Support and drive continuous improvements consistent with the site strategy and ensure compliance to all applicable state, federal and international regulations.

• Manage activities of self in achieving defined Quality goals in an efficient, accurate and timely manner.

• Collaborate effectively and work cross-functionally in a team environment.

• May perform other duties as assigned.

What you bring to Takeda:

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:

• In general, the position requires a combination of sedentary and physical work. Physical demand level is medium.

• Total standing and walking can be up to 7 or 9 hours in and 8 or 10 - hour workday (depending upon shift schedule requirements). 

• Rarely Lifting - Up to 50 pounds; Frequent Lifting 15 - 35 pounds.

• Frequent pushing/pulling - required in some positions to inspect equipment, access alternative areas of facility, move labeling carts. 

• Occasional overhead reaching - to obtain and place materials for inspection or reach needed materials. 

• Occasional squatting – to observe materials and equipment at the floor level.

• Frequent hand/finger feel - required to handle the individual packages and handle small fine parts.  Parts will have multitudes of textures and sizing

• Frequent gripping/grasping - required to use hand tools and possible other equipment to assist in the manufacturing and quality assurance of products.

• Normal office environment, Manufacturing Clean Room and Warehouse areas.

• 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.

• May be required to manage hazardous wastes in compliance with company procedures & State/Federal/Local hazardous waste regulations. Duties may include identifying, handling, generating, accumulating, storing, labeling, and on-site transporting of hazardous wastes.

• Requires weekend and possibly holiday work.

• May be required to beyond scheduled shift hours or be assigned to a different shift as needed.

• Will interact with other people; pace may be fast and job completion demands may be high.

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

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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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Job Exempt