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Sr Quality Control Technician I

1 month ago

Social Circle, 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

About the role:

The primary responsibility is to ensure compliance with procedures and regulatory requirements in the manufacturing facility. You are responsible for quality support and oversight of manufacturing operations, which includes presence on the floor and for performing Acceptable Quality Limit (AQL) sampling of finished product. Additional responsibilities include assessment for potential issues on the floor, raw material investigations, Quality on the Shop Floor (QOTSF), online batch documentation review, sample management, kitting of batches, and raw materials release.

How you will contribute:

  • Help develop lab test methods on raw materials, initial, in-process and final products, and samples collected from environmental monitoring programs at Shire manufacturing facilities.
  • Help with the installation and validation of laboratory instrumentation and computer systems to collect and record data.
  • Perform advanced assays requiring precise analytical skills and understanding of microbiology and chemistry principles.
  • Complete all testing, including special project / protocol testing.
  • Maintain data integrity and ensure compliance with company SOPs and specifications, FDA, GLP, QSR and cGMP regulations.
  • Investigate deviations and write exception documents.
  • Participate in functions involving teams, which impact production, increase efficiency, create cost savings and improve quality.
  • Perform laboratory and manufacturing audits. Audit and update, plant SOPs.
  • Perform equipment maintenance and calibrations.
  • Willingness to train others and communication with supervisors and peers
  • Advanced laboratory skills and basic knowledge of statistical method.
  • Knowledge of laboratory equipment including autoclaves, incubators, and analytical equipment.
  • Proficiency in different mathematical operations and calculations and be able to work with both the metric and US standards of measurement.
  • Knowledge of Microsoft Word, Excel, and PowerPoint.
  • Knowledge of basic chemical and biological safety procedures.What you bring to Takeda:
    • Bachelor's Degree in Chemistry, or Biological Science with Analytical Chemistry or Microbiology Laboratory coursework and 0-3 years' experienceImportant 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 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 artificial fingernails while in the manufacturing environment.
      • Work in a cold, wet environment.
      • Work multiple shifts, including weekends, or be asked to work supplemental hours.
      • 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.

        #GMSGQ #ZR1

        #LI-Onsite

        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 - GA - Social Circle - Hwy 278

        U.S. Hourly Wage Range:$22.55 - $35.43

        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 - GA - Social Circle - Hwy 278

        Worker Type

        Employee

        Worker Sub-Type

        Regular

        Time Type

        Full time