Quality Control Analyst II

at  Takeda Pharmaceutical

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JOB DESCRIPTION

Job Title: Quality Control Analyst II
Location: Brooklyn Park, MN

KEY SKILLS, ABILITIES, AND COMPETENCIES

Additional skills include, but are not limited to:

• QC Analytical Skill Set – HPLC, UPLC, Appearance, Concentration, pH, Capillary Electrophoresis, Osmolality, TOC, strong micropipetting skills
• QC Bioassay Skill Set – ELISAs, Cell Maintenance, Cell-Based Assays, Gels, icIEF, Aseptic Technique, strong micropipetting skills
• QC Micro Skill Set – Contamination control, Endotoxin, Bioburden, Environmental Monitoring, Manufacturing Cleanrooms, Aseptic Technique, Critical Utility systems

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

OTHER / TRAVEL REQUIREMENTS:

• 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.
• Willingness to travel to various 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.

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.

ABOUT THE ROLE:

Independently build and review routine in-process, drug substance, and stability test methods promptly. 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). Conduct test methods including samples generated for facility monitoring (i.e., Environmental Monitoring and Critical Utilities), in-process, drug substance, and stability. Oversee and author quality system events (i.e., laboratory investigations, deviations, CAPA’s and change controls).

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 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.
• 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