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Job Description

Job Title: Quality Analyst II
Location: Thousand Oaks, CA

About the role:

This role is responsible for performing the day-to-day quality operations for product Batch Disposition within the Quality organization. You will identify and assess quality risks in activities and processes according to regulatory agency rules, guidelines, and Takeda quality practices. You will comprehensively assess critical criteria related to product batch disposition to ensure adherence to lead times.

How you will contribute:

• Responsible for verification of Manufacturing documentation against Standard Operating Procedures (SOPs) for accuracy, compliance to procedures based on regulatory requirements and internal guidelines, and acceptance criteria as part of the batch records release process.

• Identify areas of nonconformance and escalate to management (Manufacturing and Quality) for initiation of a Deviation.

• Administer and maintain relevant databases, prepare, and issue reports defined by the area, and develop custom reports as needed.

• Assist in external and internal audits/inspections by maintaining audit records, extracting data from databases, creating reports, collecting relevant data, etc. 

• Audit/review documents as needed for completeness, CGMP’s, company procedures and verification of data. Correct any deficiencies found.

• Maintain and update departmental business indicators and prepare metrics for the Management Review of Quality Systems.

• Conduct, perform, and/or review investigations for non-conformances within respective area. Assist in identifying corrective actions to prevent recurring non-conformances.

• Assist in the development, review, and revision of SOPs in support of Division Procedure Compliance and continuous improvement efforts as needed.

• Drive continuous improvement projects within the department for efficiency and compliance related to the disposition process and related processes.

• Assist and/or prepare technical reports (e.g., YBPR)

• Assist in training Quality team members.

• Support internal/external inspections/audits as SME.

• Support process with timely closure of observations/audit items.

• Serve as a team member and/or assist in CAPA Investigations for significant issues within respective area.

• May perform other duties as assigned.

• Strong interpersonal skills and great attention to detail are necessary.

• Strong team player with effective communication skills and able to handle multiple projects concurrently.

• Able to apply problem solving tools and methods to coordinate and/or lead investigation teams.

• Knowledge of FDA regulations, Application of Good Laboratory Practices and Application of Good Manufacturing Practices and Good Documentation Practices.

• Proficient with Microsoft Excel, Word, PowerPoint, PAS X.

What you bring to Takeda:

• High school diploma or equivalent required.

• Associate degree in a scientific discipline or bachelor’s degree in a scientific discipline preferred.

• Minimum of 3 to 5 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 overall physical exertion of this position is sedentary.

• May be required to walk occasionally when retrieving batch records from the records vault, attending meetings, and visiting the manufacturing areas for observation.

• Normal office environment; inside working 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.

• Required to work 5 days a week, 8-hour days.

• May require overtime, weekend, and holiday work to support production.

• May be required to work 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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