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Job Description

Job Title: QC Analyst II

Location: Lexington, MA

About the role:

Primary responsibilities of this position will focus on the daily lab operations and execution of testing to support manufacturing operations. You will maintain operational and GMP readiness of the QC areas. Also, you will participate in more complex projects, Operational excellence projects and multiple quality systems. You will report to the Quality Control Supervisor.

How you will contribute:

• Assays range from pH, enzyme concentration to more complex assays such as SDS silver Gels, PCR, DNA and enzyme activity.
• Testing may include samples from drug substance and drug product, manufacturing, stability, raw materials and multiple protocol studies using test methods.
• You will participate in more complex projects, Operational excellence projects and different quality systems.
• Biochemistry Focus: A280, SOLO A280, Compedia methods (pH. Moisture, OSMO, Appearance, Subvisible particles), Enzyme Actitity assays, DNA, PCR, Free Thiol
• QC operations support which requires data review, data trending, OE/5S initiative, maintenance of equipment and reagents, reagent prep, lab house keeping, support for other QC groups.
• Compliance and quality systems (SOP revisions, input to quality system records)
• Solve routine problems of limited scope and complexity following established procedures. Work on problems of limited scope. Follow standard practices in analyzing situations of data from which answers can be obtained. Build stable working relationships internally.

What you bring to Takeda:

• Bachelor's degree and minimum of 2-5 years related experience
• Previous experience in a GMP QC role would be ideal.
• Previous experience in a GMP QC role
• LIMS, SAP, Trackwise, EDMS, Compliance and science understanding

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. You may:

• 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.
• Need to remove all make-up, jewelry, contact lenses, nail polish and artificial fingernails while in the manufacturing environment.
• Repetitive bending and reaching to set up and break down equipment
• Ability to walk and stand for periods of time.
• Individual may participate in environmental chamber monitoring program which would include the use of an on-call mobile phone and on-site support during non-business hours.
• Work in a cold, wet environment.
• Work multiple shifts, including weekends, or be asked to work supplemental hour.
• Work around chemicals such as alcohol, acids, buffers and Celite that may require respiratory protection.
• Limited to no travel expected.

More about us:

At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and the best patient support programs. Takeda is a patient-focused company to 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.

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