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Quality Assurance Validation in Training

2 months ago

Thousand Oaks, United States Takeda Full time

By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’sPrivacy Noticeand Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.

Job Description

Job Title: Quality Assurance Validation in Training

Location: Thousand Oaks, CA

About the role:

You will focus on developing and maintaining high standards of documentation and compliance within the Quality Assurance Validation (QAV) team. Your work will involve a blend of training development, document management, and quality assurance tasks to ensure efficient operations and adherence to regulatory requirements.

How you will contribute:

  • Develop an on-the-job training plan with learning objectives with your area leader.
  • Assist the QAV team in filing paper Qualification documents. Manage the QAV Vault, follow up with 'borrowers' on documents that have been checked out.
  • Follow up with borrowers on returning documents and ensure returned documents are filed in designated locations.
  • Perform periodic housekeeping of QAV Vault to maintain in an 'audit ready state'.
  • Perform preliminary reviews of paper GxP documents for GDP errors. (Risk Assessments, Specification, Protocols, Protocol Executions, Interim and Final Reports)
  • Maintain QAV Sharepoint sites (Monthly Tracker, Data Integrity Site). Develop additional (Teams/Sharepoint) sites.
  • Assist with retrieving and updating metrics for QAV Quality presentations.
  • Perform any other duties as assigned.

    What you bring to Takeda:

    • High School degree or equivalent required; bachelor's degree in chemistry or Biological Sciences desirable
    • Minimum 1 year of related experience in quality operations or equivalent years in biotechnology, pharmaceutical or similar GMP manufacturing environment desirable.
    • General knowledge with cGMP manufacturing, regulatory regulations and requirements desirable.

      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.
      • 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.
      • The role and schedule will be reassessed after each semester/summer break to align with school schedules.

        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.

        #GMSGQ

        #ZR1

        Takeda 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 - Thousand Oaks - Rancho Conejo

        U.S. Hourly Wage Range:$18.85 - $29.62

        The estimated hourly wage range reflects an anticipated range for this position. The actual hourly wage 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 hourly wage 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 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.

        Locations

        USA - CA - Thousand Oaks - Rancho Conejo

        Worker Type

        Employee

        Worker Sub-Type

        Regular

        Time Type

        Part time