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Quality Control Analyst I

Company: Takeda Pharmaceutical
Location: Saint Paul
Posted on: August 5, 2022

Job Description:

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 s Privacy Notice and 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:Join Takeda as a Quality Control Analyst I where you will perform supportive activities for general lab readiness, laboratory equipment qualification and method transfers. You will conduct important biological test methods including samples generated for in-process, drug substance and stability. You will use a variety of laboratory instrumentation and computer systems to collect and record data (such as LIMS and Empower). You will follow SOPs to perform methods requiring precise analytical skills and understanding of biology and chemistry principles. As part of the Quality Control team, you will report to the Manager of Quality Control.How you will contribute:

  • You will demonstrate a functional understanding of a laboratory setting and Standard Operating Procedures (SOPs).
  • Work within laboratory environment for extended periods of time, conducting analytical tests, reviewing analytical data, maintaining laboratory materials and instruments and other laboratory functions
  • You will complete all testing, including special project / protocol testing.
  • Maintain data integrity and ensure compliance with company SOPs, specifications, and cGMP regulations.
  • You will define Quality Control practices to determine appropriate action.
  • Initiate low severity level deviations, CAPAs and change controls within the electronic Quality Management System.
  • You will occasionally participate in functional efforts involving teams to solve problems of moderate scope where analysis of situations or data requires a review of identifiable factors.
  • Author minor revisions to existing SOPs.
  • You will receive general instructions on routine work and detailed instructions on new assignments.
  • May work overtime or be assigned to a different shift.
  • May perform equipment maintenance and calibrations.Minimum Requirements/Qualifications:
    • Bachelor's and/ or Master's degree in any Life Sciences with relevant laboratory coursework.
    • Less than 3 years of relevant experience.
    • Previous experience in a regulated environment desirable.
    • You will must understand laboratory instrumentation.
    • You will work in a team environment.
    • You will have knowledge of cGMP manufacturing.
    • You will have knowledge of basic chemical and biological safety procedures.
    • QC Analytical Skills - HPLC, Appearance, Concentration, pH, CE, Particulate Matter, Osmolality.
    • QC Bioassay Skills - ELISAs, Cell Maintenance, Cell-Based Assays, Gels.
    • QC Micro Skills - Endotoxin, Bioburden, Environmental Monitoring, Cleanrooms, Aseptic technique, pharmaceutical water systems.What Takeda can offer you:
      • Comprehensive Healthcare: Medical, Dental, and Vision
      • Financial Planning & Stability: 401(k) with company match and Annual Retirement Contribution Plan
      • Health & Wellness programs including onsite flu shots and health screenings
      • Generous time off for vacation and the option to purchase additional vacation days
      • Community Outreach Programs and company match of charitable contributions
      • Family Planning Support
      • Flexible Work Paths
      • Tuition reimbursementMore 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.In accordance with the CO Equal Pay Act, Colorado Applicants Are Not Permitted to Apply.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 Brooklyn Park, MN Worker Type Employee Worker Sub-Type Regular Time Type Full time

Keywords: Takeda Pharmaceutical, St. Paul , Quality Control Analyst I, Professions , Saint Paul, Minnesota

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