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Job Description

About the role

As a Quality Assurance Specialist I, you will manage Deviations (Events) and Corrective and Preventive Actions (CAPAs) within Takeda's Quality Systems program. It involves collaborating with plasma suppliers to ensure ongoing communication and to monitor the resolution of identified discrepancies. Furthermore, we are looking for the tracking and trending of relevant data, as well as the preparation and presentation of monthly and quarterly metrics in alignment with established Key Performance Indicators (KPIs). You will report to Supervisor Quality Systems.

This is currently a hybrid role, requiring in-office presence three days a week.

How you will contributeManage and resolve internal/external deviations and CAPAs in Takeda's Quality Systems for plasma, operations, supply chain, and suppliers.Document, investigate, and ensure closure of discrepancies using the PQR Quality System.Conduct process audits and maintain regulatory and SOP compliance; improve initiatives.Oversee Quality vault management, ensuring proper check-in/out, filing, and retention of records per SOPs.Review, and revise department-owned procedures and documents in Veeva to ensure compliance.Perform quality reviews/dispositions of plasma lots and shipments, including managing holds or releases in APDS and ensuring destruction of unsuitable units.Execute Lookback activities and document PDI notifications from plasma suppliers within set timelines.Lead continuous improvement projects and internal/external audits, supporting closure of observations.Prepare and deliver process performance updates and metrics to stakeholders and management.Communicate with quality, manufacturing, support groups, and suppliers to ensure plasma availability and resolve discrepancies; maintain forklift certification

What you bring to Takeda:BA / BS degree in Life Sciences and/or Business required or equivalent experience.Proficient/Intermediate knowledge of MS Office (Word, Excel, Visio, and PowerPoint).Minimum 2 years of experience in the Plasma / Whole Blood Industry or Biopharmaceutical / Biotech would be ideal.Minimum 2 years of experience in a quality organization would be ideal.Maintaining certification on Powered Industrial Truck use (Forklift) is highly desirable. Knowledge in computerized systems (e.g., APDS, TrackWise, C3ME, or other inventory management or quality systems software would be ideal.Possess in-depth knowledge of regulatory, quality, and FDA requirements (cGMP, GDP) relevant to Biologics.Write clearly, present effectively, and convey technical information to diverse audiences.Exhibit organizational, analytical, and problem-solving abilities.Proficient in Qlik, and Power BI for data management and reporting tasks.Lead, motivate, and train team members, acting as a catalyst for change and continuous improvement.Collaborate diplomatically across functions, with suppliers, and support audit readiness and process compliance.Identify process gaps, recommend solutions, and communicate issues and actions to management.

Important ConsiderationsMust be able to lift, push, pull, and carry up to 50 lbs.The position requires a combination of sedentary work and walking around observing conditions in the facility.Must be able to work in cold temperature conditions ranging from -28°C-+8°CMust be able to wear special personal protective equipment required in cold environments over the head, face, hands, feet, and body.Must be able to sit/stand for prolonged periods.Some walking across the facility between various plasma management areas is necessary, including the use of stairs.Must be able to work multiple shifts, including weekends.Must be able to work extra as required.

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.

BioLife Compensation and Benefits Summary

We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. 

For Location:

USA - CA - Van Nuys

U.S. Base Salary Range:

$56,000.00 - $88,000.00

The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job.  The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location. 

U.S. based employees may be eligible for short-term and/or long-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.

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.

LocationsUSA - CA - Van Nuys

Worker TypeEmployee

Worker Sub-TypeRegular

Time TypeFull time

Job Exempt

Yes