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Job Description

About the role:

As a Quality Control Analyst, you will execute and review routine in-process, drug substance, and stability test methods. You will maintain lab operations (including cleaning, ordering of supplies, reagent preparation, stocking, waste disposal) and conduct test methods including samples generated for facility monitoring (i.e., Environmental Monitoring and Critical Utilities), in-process, drug substance, and stability. You will own and author quality system events (i.e., laboratory investigations, deviations, CAPA's and change controls).

How you will contribute:

• Use a variety of laboratory instrumentation and computer systems to collect and record data (such as LIMS, SoftmaxPro, Charles River Endoscan, MODA, and Empower).
• Demonstrate a functional and basic theoretical understanding of laboratory operations and Standard Operating Procedures.
• 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) procedures and practices in selecting methods and techniques to troubleshoot problems and/or formulate 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 practices.
• May work overtime or be assigned to a different shift.
• Perform equipment maintenance and calibrations.

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.
• Must be able to read, write, and converse in English.
• Use databases for the purposes of work execution, training, performance management, and self-service.
• Knowledge of cGMP manufacturing
• Knowledge of chemical, biological and/or microbiological safety procedures.
• QC Analytical Skills – HPLC, UPLC, Appearance, Concentration, pH, Capillary Electrophoresis, Osmolality, TOC, or strong micro pipetting skills
• QC Bioassay Skill Set – ELISAs, Cell Maintenance, Cell-Based Assays, Gels, icIEF, Aseptic Technique, micropipetting skills
• QC Micro Skills – Contamination control, Endotoxin, Bioburden, Environmental Monitoring, Manufactuirng Cleanrooms, Aseptic Technique, Critical Utility systems

How you will contribute:

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:

Work in a controlled environment requiring special gowning and wear protective clothing over the head, face, hands, feet and body. This may include additional hearing protection for loud areas.

• 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 -> Must be able to remain in a stationary or standing position for extended periods of time in both office and laboratory environment.
• Carry weight, lifting - Frequently move laboratory ma