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Job Description

Job Title: Quality Analyst
Location: Thousand Oaks, CA

About the role:

The Quality Analyst will be responsible performing the daily quality operations for Quality Lab Services within the Quality organization. You will manage stability management, basic investigation activities, coordinating external lab testing, managing analytical instrument preventive maintenance, inventory management, compiling critical quality attributes data for the Product Quality review and Yearly Biologic Product Report, initiating deviations, and participating in quality process improvements for the QC labs. You will report to the AQC Manager.

How you will contribute:

• Help manage the stability process for the Thousand Oaks Site.
• Conduct basic laboratory investigation activities, including LI initiation and investigation. Ensure roadblocks are identified and resolved, keeping LIs on track to meet target closure dates.
• Initiate deviations and support sample discrepancy report investigations.
• Identify areas of non-conformance and notify management per the deviation management process.
• Coordinate external lab testing such as Adynovate, Advate, Rixubis, and Vonvendi product release testing by sister sites, general safety and pyrogen, Hepatitis B Surface Ag, and particulate matters by OFI.
• Process results from external labs on a to ensure no/minimal impact to product release.
• Prepare annual Product Quality Review (PQR) and Yearly Biologic Product Report (YBPR) for products.
• Manage analytical instrument preventive maintenance process for QC labs. Work with vendors to schedule PMs.
• Be a team member and help with investigations for issues within respective area.
• Maintain departmental business indicators. Prepare metrics for the Management Review of Quality Systems.
• Help with external and internal audits by maintaining audit records, extracting data from databases and creating reports, collecting relevant data, etc. 
• Support process with closure of observations/audit items.
• Identify and participate in process improvements within respective area. 
• May write, review important documents, records, and reports such as Standard Operating Procedures (SOPs) for accuracy and compliance to procedures based on regulatory requirements and internal guidelines, etc.
• Escalate and communicate promptly.
• Administer and maintain relevant databases, preparing and issuing reports as defined by the area.
• Participate in DMAIC and LEAN projects to help the department and facility meet continuous improvement objectives. 
• Knowledge of basic laboratory functions, test methods, equipment (including but not limited to analytical equipment, autoclaves, incubators, and environmental monitoring equipment), processes and applicable procedures.
• Basic knowledge of FDA Regulations, Application of Good Laboratory Practices, Application of Good Manufacturing Practices and Application of Good Documentation Practices.
• Fundamental understanding of change control practices for major equipment, critical systems, instrumentation, and computerized systems.
• General knowledge of quality systems including deviation management, change control, document control, etc.
• Write detailed investigation summary memos that meet the requirements of the Takeda Quality Organization and the expectations of regulatory agencies.
• Demonstrate understanding in how to implement investigation strategies and apply root cause failure analysis.

What you bring to Takeda:

• Bachelor’s degree in chemistry or Biological Sciences would be ideal.
• Minimum 1 year of related experience in quality operations and/or equivalent years in biotechnology, pharmaceutical or similar GMP manufacturing environment would be ideal.
• Experience with SQL LIMS, Labware, MODA, JDE, and ARIBA would be ideal.
• Documented/Certified training in DMAIC and LEAN concepts would be ideal.
• Proficiency with the MS Office suite of programs (including Microsoft Word, Excel, and PowerPoint)

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 requires light to medium work.
• Laboratory environment; inside working conditions
• Must wear personal protective equipment due to safety requirements in designated lab 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 waste 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. 
• May work around Methotrexate, which is a known cell growth inhibitor.
• May require immunization before performing work within the manufacturing area.
• Maybe required to work weekends and holidays.
• 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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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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