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Job Description

Job Title: Quality Control Analyst I

Location: Brooklyn Park, MN

About the role:

You will report to the Team Lead- Quality Control

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

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.
• Complete all testing, including special project and protocol testing.
• Maintain data integrity and ensure compliance with company SOP's, specifications, and cGMP regulations.
• 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.
• Author minor revisions to existing SOP's.
• Receive general instructions on routine work and detailed instructions on new assignments.

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.
• Previous experience in a regulated environment.
• Laboratory instrumentation experience preferred.
• Knowledge of cGMP manufacturing preferred.

Other Job Requirements

Physical Demands:

• Stand or sit -> Must be able to remain in a stationary or standing position for extended periods of time in both office and laboratory environment.

In certain areas of Quality Control, the following may apply:

• 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 stairs to collect samples.
• Dexterity/balance – required to gown for cleanroom work, balance and dexterity.

Other / Travel Requirements:

• 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.
• May participate in an on-call rotation for off-shift coverage or occasionally work off-shift hours to help support a 24-7 manufacturing department.
• Additional preferred skills include, but are not limited to:
  • QC Analytical Skills – HPLC, UPLC, UV-Vis, Appearance, Concentration, pH, CE, Osmolality, TOC, strong micropipetting skills
  • QC Bioassay Skill Set – ELISA's, Cell Maintenance, Cell-Based Assays, plate readers, Gels, icIEF, Aseptic Technique, strong micropipetting skills, biosafety cabinets
  • QC Micro Skills – Endotoxin, Bioburden, Environmental Monitoring, Manufacturing Cleanrooms, Aseptic Technique, Critical Utility systems

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