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Job Description

Job Title: Quality Control Analyst I

Location: Brooklyn Park, MN

About the role:

You will execute routine in-process, drug substance, and stability test methods using a variety of laboratory instrumentation and computer systems to collect and record data (such as LIMS, SoftmaxPro, Charles River Endoscan, MODA, and Empower). You will also maintain lab operations (including cleaning, ordering of supplies, reagent preparation, stocking, waste disposal).

You will work 2:00pm-10:30pm Monday-Friday.

This is an on site role that reports to the Team Lead, Quality Control.

How you will contribute:

• Demonstrate a functional understanding of a laboratory setting and Standard Operating Procedures (SOP's).
• Work within laboratory environment for extended periods of time, conducting facility monitoring (i.e., Environmental Monitoring and Critical Utility Monitoring) and product tests, reviewing data, maintaining laboratory materials and instruments and other laboratory functions. Participate in cross-functional collaboration with internal departments (i.e., Quality, Manufacturing, Engineering, Metrology).
• Complete all testing, including special project and protocol testing.
• Maintain data integrity and ensure compliance with company SOP's, specifications, and cGMP regulations. Author minor revisions to existing SOP's.
• Support low risk deviations, CAPA's and change controls within the electronic Quality Management System.
• Initiate and own laboratory investigations. Occasionally participate in department problem-solving.
• Receive general instructions on routine work and detailed instructions on new assignments.
• May work overtime or be assigned to a different shift as needed.
• Perform equipment maintenance and calibrations.
• Complete mandatory training within required timeframe and perform other duties as assigned.

What you bring to Takeda:

• Bachelor's or Master's degree in any Life Sciences with relevant laboratory coursework.
• 0-3 years of relevant experience.

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:

• Need to remove all make-up, jewelry, contact lenses, nail polish and/or 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, as necessary.
• Work around chemicals such as alcohol, acids, buffers and Celite that may require respiratory protection.
• Stand or sit and remain in a stationary or standing position for extended periods of time in both office and laboratory environment.
• Carry weight, lifting - Frequently moves laboratory materials and portable instruments weighing up to 30 pounds.
• Climb - Occasionally ascends/descends step ladders to reach materials and/or stairs to collect samples.
• 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.
• May be required to participate in an on-call rotation for off-shift coverage or occasionally work off-shift hours to help support a 24-7 manufacturing department.
• Travel to meetings or training, this could include overnight trips. Requires 0-5% travel

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-MA1 #LI-Onsite

Takeda Compensation and Benefits Summary

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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.

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