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Job Description

Job Title: Quality Analyst II

Location: Thousand Oaks, CA

About the role:

You will perform the daily quality operations. You will identify and assess quality risks in activities and processes according to regulatory agency rules, guidelines, and Takeda quality practices.

How you will contribute:

• Review important documents, against Standard Operating Procedures (SOPs) for accuracy and compliance based on regulatory requirements and internal guidelines.

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

• Conduct, perform investigations for non-conformances within respective area. Help identify corrective actions to prevent recurring non-conformances.

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

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

• Support process with closure of observations/audit items.

• Be a team member and help with CAPA Investigations for issues within respective area.

• Maintain departmental business indicators.

• Prepare metrics for the Management Review of Quality Systems.

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

• Assist and prepare Annual Product Review (APR) for products.

• Write Technical reports (e.g., PQR and YBPR).

• Help with the development, and revision of SOPs to support Division Procedure Compliance and continuous improvement efforts.

• Help train Quality team members.

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

What you bring to Takeda:

• High school diploma or equivalent required.

• Bachelor's degree in a scientific discipline.

• 3+ years of related work experience.

What Takeda can offer you:

• Comprehensive Healthcare: Medical, Dental, and Vision

• Financial Planning & Stability: 401(k) with company match and Annual Retirement Contribution Plan

• Health & Wellness programs including onsite flu shots and health screenings

• Generous time off for vacation and the option to purchase additional vacation days

• Community Outreach Programs and company match of charitable contributions

• Family Planning Support

• Professional training opportunities

• Tuition reimbursement

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:

• The physical exertion of this position is sedentary.

• Batch record Review on the Floor (BRR) may require being on your feet for long periods of time.

• Normal office environment.

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

• 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.

• May require immunization before performing work within the manufacturing area.

• May require overtime, weekend, and holiday work.

• May be assigned to a different shift.

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.

Base Salary Range: $53,000.00 - $76,000.00. Employees may also be eligible for Short-term and Long-Term Incentive benefits. Employees are eligible to participate in Medical, Dental, Vision, Life Insurance, 401(k), Charitable Contribution Match, Holidays, Personal Days and Vacation, Tuition Reimbursement Program and Paid Volunteer Time Off.

The final salary offered for this position may take into account many factors including location, skills, education, and experience

This posting excludes Colorado applicants.

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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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