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Job Description

About the role:

As as Quality Control Analyst I, you will focus on the daily lab operations and execution of testing to support manufacturing operations. Testing may include samples from drug substance and drug product, manufacturing, stability, raw materials and multiple protocol studies using test methods. The assays range SEC and Reverse Phase methods to more complex assays such as Peptide Mapping and Glycan Mapping by 2-AB. You will maintain operational and GMP readiness of the QC areas. Also, you will participate in more complex projects, Operational excellence initiatives and multiple quality systems. You will report to Quality Control Manager.

This is an on site position.

How you will contribute:

• Test execution, participate in training analysts, trouble shooting of methods
• QC operations support which requires data review, data trending, 5S activities, maintenance of equipment and reagents, reagent preparation, lab house keeping, support for other QC groups.
• Role is responsible for HPLC Focus: SEC, RP methods, C-Term, %FG, Peptide Mapping, Glycan Mapping 2-AB, and other methods.
• Compliance and quality systems (SOP revisions, input to quality system records)
• Solve routine problems of limited scope and complexity following established policies and procedures.
• You will work on problems of limited scope.
• You will follow standard practices and procedures in analyzing situations of data from which answers can be readily obtained.

What you bring to Takeda:

• Bachelor's degree and 0+ years of experience. (science related degree would be ideal)
• Use basic principles, theories and concepts.
• Limited knowledge of industry standards. We ask that you have critical thinking.
• Experience with MS Office, LIMS, SAP, Trackwise, EDMS, Compliance and strong science understanding would be ideal.

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:

• 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.

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

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.

For Location:

USA - MA - Lexington - BIO OPS

U.S. Base Salary Range:

$56,000.00 - $88,000.00

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.

Locations

USA - MA - Lexington - BIO OPS

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

Job Exempt

Yes

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.