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Job Description

About the Role:

As the Quality Systems Analyst II, you will participate in the daily Quality System department activities for Thousand Oaks including Change Control, Deviations, CAPA, and Quality Documentation.

This is an on site position and you will report to the Quality Systems Manager.

How you will contribute:

• Support Change Control, Deviation, CAPA and continuous improvement initiatives.

• Review quality related documentation and approval of Deviations/CAPA and Change Control including evaluating the impact to the process and product as applicable.

• Complete and approve nonconformance investigations and change control requests in accordance with Quality system requirements.

• Revise SOPs and forms to refine the process and maintain compliance. Support the development and revision of standard operating procedures.

• Proactively participate in assessing Quality system processes. Assist as a system administrator for quality systems electronic solutions.

• Coordinate and conduct facility training related to Quality Systems.

• Trend and analyze data, and present Quality System indicators to all organizational levels.

• Support internal audits as subject matter expert through participation during audits, responses, and closure of commitments, which includes providing quality systems line lists and reports. Support process with timely closure of observations/audit items.

• Work and build relationships with departments such as manufacturing, engineering, technical groups (validation, automation), laboratories, maintenance, metrology, and utilities to drive quality culture and compliance.

• Provide backup support for Quality Compliance tasks and perform other duties as assigned.

What you bring to Takeda:

• Bachelor's degree in sciences or engineering preferred with minimum of 3 years of experience in Quality Assurance, QC/QA analysis biotechnology, biologics, or pharmaceutical manufacturing facility or master's degree in science or engineering with some experience.

• General knowledge of quality systems including nonconformance management, change control, document control, product release, supplier quality.

• General knowledge of cGMP manufacturing and processes.

• Proficient in Microsoft Excel, with advanced skills in data analytics, pivot tables, and VLOOKUP.

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:

• 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.

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

• Work in a cold, wet environment.

• Work multiple shifts, including weekends, or be asked to work supplemental hours, as necessary.

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

• Mostly sedentary work: lifting no more than 10 pounds at a time and occasionally lifting or carrying articles like files and ledgers

• Normal office environment

• May be required to work overtime or be assigned to a different shift 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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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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