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Job Description

Job Title: Quality Analyst II

Location: Thousand Oaks, CA

About the role:

As a Quality Analyst II, you will perform the daily quality operations for Quality Lab Services within the Quality organization. You will also perform stability management, investigate laboratory investigations, coordinate 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, initiate deviations, and participate in quality process improvements for the QC labs. You will report to the AQC Manager.

How you will contribute:

• Manage the stability process for the Thousand Oaks Site and serve as stability Subject Matter Expert during inspections.

• Lead laboratory investigation activities, including LI initiation, investigation, and leading cross-functional meetings as related to the LI. Ensure roadblocks are identified and resolved, keeping LIs on track to meet target closure dates.

• Initiate deviations and support sample discrepancy report investigations.

• Coordinate external lab testing such as Advate, Rixubis, and Vonvendi product release testing by sister sites, general safety and pyrogen, Hepatitis B Surface Ag, calculated values for Rixubis and Vonvendi, and particulate matters by OFI.

• Process results from external labs 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, initiate purchase orders in ARIBA, and advance work orders in JDE.

• Receive and process chemical.

• Be a team member and/or help with investigations for important issues within respective area.

• Maintain and update 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.

• Write, revise, and/or review Standard Operating Procedures (SOPs) and forms for accuracy and agreement to global procedures based on regulatory requirements and internal guidelines, etc.

• Escalate and communicate ambiguous situations in a timely manner.

• Take ownership and resolve issues related to LIs, deviations, and other processes the Lab Support team manages.

• May perform other duties as assigned.

What you bring to Takeda:

• Bachelor's degree in chemistry or Biological Sciences would be ideal.

• Minimum five (5) years of experience in quality operations and/or equivalent years in biotechnology, pharmaceutical, or a similar GMP manufacturing environment would be ideal.

• In-depth understanding of the stability process.

• In-depth understanding of lab investigation practices.

• In-depth knowledge of quality systems including deviation management, change control, document control, etc.

• Documented/certified training in DMAIC and LEAN concepts ideal.

• Write detailed investigations that meet the requirements of the Takeda Quality organization and the expectations of regulatory agencies, implement investigation strategies, and apply root cause failure analysis.

• Knowledge of laboratory functions, test methods, equipment (including analytical equipment, lab processes, and applicable procedures).

• Able to handle/prioritize multiple projects concurrently meeting established deadlines and changing priorities.

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

• Proficient in SQL LIMS, Labware, Discoverant, Adobe, Trackwise, JD Edwards, Ariba, SAP, Veeva, and MS Office suite (including Word, Excel, PowerPoint, and Visio) would be ideal.

• Proficient in multiple mathematical disciplines and can use statistical tools such as Change Point Analysis and MiniTab.

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:

• May be required to wear personal protective equipment (PPE) and other clean room garments daily. This may include safety shoes, safety glasses, aprons, face shields, lab coats, full body gowns, hair nets and gloves and hearing protection.

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

• Laboratory environment; inside working conditions

• May be required to wear personal protective equipment or work in controlled environments 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 chemicals such as alcohol, acids, buffers and other hazardous or biohazardous materials that may require special protection.

• May be required to work overtime, weekends, holidays or be assigned to a different shift as needed.

• The overall physical exertion of this position is sedentary.

• Occasional physical work processing incoming chemicals/reagents.

• 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.

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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