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Job Description

Job Title: Quality Control Analyst II

Location: Brooklyn Park, MN

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).

How you will contribute:

• Demonstrate a functional and basic theoretical understanding of laboratory operations 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.
• Independently exercise judgment within generally defined Quality Control (QC) practices in selecting methods and techniques to troubleshoot problems or create solutions.
• Decisions have moderate impact on future QC processes that impact batch disposition.
• Initiate and own laboratory investigations, basic complexity low and medium risk deviations, CAPA's, and change controls of moderate scope within the electronic Quality Management System.
• Draft studies and investigations of moderate scope and work on problems where the situation or data requires a review of identifiable factors.
• Author new SOP's and initiate changes to existing procedures.
• Train new QC Analysts on routine procedures.

Complexity and Problem Solving

• Employee at this level is involved in routine tasks of moderate scope and complexity.
• Employee receives instructions on new work and refers to procedures for guidance.
• Conduct independent work from trainers and more senior staff.
• Contribute to moderate scope decisions founded on sound principles, international industry/regulatory standards, and scientific basis.
• Understand the needs of important collaborators (i.e., Manufacturing Operations, Quality Assurance, Validation and Quality Systems) to provide compliant test results.

Internal and External Contacts

• Participate in collaboration with internal departments (i.e., Quality, Manufacturing, Engineering, Metrology, and Business Excellence).

What you bring to Takeda:

• Bachelor's degree in any Life Sciences with relevant laboratory coursework
• 3+ years of experience.
• Previous experience in a regulated environment.
• Must understand laboratory instrumentation.
• Knowledge of cGMP manufacturing
• Knowledge of chemical, biological and microbiological safety procedures.

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.

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:

• 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.

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

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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