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Job Description

Job Title: Quality Control Analyst II

Location: Lexington, MA (USA)

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 samples from in process, drug substance/product and multiple protocol studies using analytical test methods derived from non-compendial sources. This is a fully on site position that reports to the QC Manager.

How you will contribute:

• You will maintain operational and GMP readiness of the QC area and act as a role model for junior staff in the QC areas.

• You will participate in more complex projects, operational excellence projects including 5S/lean improvements, method/equipment validation, method transfer and different quality systems (deviations, change controls, investigations), and maybe asked to take lead roles for the QC organization on these projects. Work is performed under general direction.

• Responsible for HPLC laboratories performing and troubleshooting a broad range of analytical based techniques such as SE-HPLC, RP-HPLC, IEX, CE-SDS, glycan and peptide analyses to support in-process, release and stability testing.

• Support commercial and clinical testing for defined site-based and external programs, and method transfer and validation. Introduce new equipment and technology to improve sustainability and compliance. Establish and recommend changes to policies which effect subordinate organizations.

• Review QC analytical assays including method qualification and validation assays.

• Perform and lead OOT, OOS, GMP Investigations, data analysis, deviation, and data trending.

• Represent organization as a prime contact on contracts or projects. Work with senior internal and external personnel on matters often requiring coordination between organization. Contacts external to QC may include: Analytical Development, R&D, Quality Assurance and other Quality functions, Regulatory , Manufacturing, Facilities and Engineering

• Receive assignments in the form of objectives and establish goals to meet objectives. Provide guidance to team members following established policies. Exert some influence on the objectives and long-range goals. Erroneous decisions or failure to accomplish goals would normally have a serious effect upon the administration of the organization.

• QC operations support which requires data review, data trending, OE/5S/LEAN projects, maintenance of equipment and reagents, lab housekeeping, support for other QC groups. Compliance and quality systems (SOP revisions, input to quality systems records).

• Work in multiple departmental and cross-functional teams and projects; inspection and regulatory support.

What you bring to Takeda:

• Bachelor's degree and 2+ years of related experience in a GMP QC role OR 4+ years of relevant experience in a GMP QC role

• 5S/OE experience.

• Method transfers/validation is preferred.

• Important Skills: MS Office, LIMS, SAP, Trackwise, Waters Empower, Thermo Fisher Chromeleon, EDMS, compliance and 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.

• Professional training and development opportunities.

• 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.

• Limited to no travel expected. Travel between sites is required.

• Repetitive bending and reaching to setup and break-down equipment (if required by specific activity).

• Walk and stand for periods of time.

• Participate in environmental chamber monitoring program which would include the use of an on-call mobile phone as well as on-site support during non-business hours.

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.

This posting excludes Colorado applicants.

#GMSGQ #ZR1 #LI-MA1

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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