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　　Job Description

　　Job Title: QC Microbiology Analyst II

　　Location: Lexington, MA

　　About the role:

　　You will focus on the daily lab operations and execution of testing to support manufacturing operations /validation/or development studies. Testing may include but not limited to samples from drug substance and drug product manufacturing, stability, raw materials and various protocol studies using test methods derived from the various compendia and non-compendial sources. May assist in sampling activities. You will be expected to maintain operational and GMP readiness of the QC areas. In addition, the individual may participate in more complex projects, operational excellence initiatives, and various quality systems with supervision. You will report to the Quality Control Supervisor.

　　The work days on this role will be TBD- Sunday - Thursday or Tuesday - Saturday

　　How you will contribute:

　　Testing execution

　　QC operations support which entails data review, data trending, OE initiatives, maintenance of equipment and reagents, lab housekeeping, support for other QC groups (if necessary)

　　Compliance and quality systems (SOP revisions, input to quality systems records)

　　Solve routine problems of limited scope and complexity following established policies and procedures.

　　Works on problems of limited scope. Follows standard practices and procedures in analyzing situations or data from which answers can be readily obtained. Builds stable working relationships internally.

　　What you bring to Takeda:

　　Requires a bachelor’s degree and a minimum of 2-4 years related experience with a science related degree.

　　Use basic principles, theories, and concepts. Limited knowledge of industry standards.

　　MS Office, LIMS, Trackwise, cGMP compliance and strong science understanding

　　What Takeda can offer you:

　　Comprehensive Healthcare: Medical, Dental, and Vision

　　Financial Planning & Stability: 401(k) with company match and Annual Retirement Contribution Plan

　　Health & Wellness programs including onsite flu shots and health screenings

　　Generous time off for vacation and the option to purchase additional vacation days

　　Community Outreach Programs and company match of charitable contributions

　　Family Planning Support

　　Flexible Ways of Working

　　Tuition reimbursement

　　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.

　　In accordance with the CO Equal Pay Act, Colorado Applicants Are Not Permitted to Apply.

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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.

　　Locations

　　USA - MA - Lexington - BIO OPS

　　Worker Type

　　Employee

　　Worker Sub-Type

　　Regular

　　Time Type

　　Full time