Qc Analyst Ii

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Job Description

Job Title: QC Analyst II

Location: Lexington, MA

About the role:

As a QC Analyst II, you will focus on the daily lab operations and execution of testing to support manufacturing operations /validation/or development studies. You will also test samples from drug substance and drug product manufacturing, stability and multiple protocol studies using approved test methods or test methods derived from QC technical protocols. You will also help with sampling activities. You will report to the Quality Control Supervisor.

How you will contribute:

• Maintain operational and GMP readiness of the QC areas and maintain important reagent inventory such as antibodies and cell banks at business appropriate quantities.

• Participate in more complex projects, and multiple quality systems with general guidance.

• 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 is expected.

• Establish and recommend changes to policies which effect subordinate organizations.

• Test execution, participate in training analysts, trouble shooting of methods.

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

• Involvement in multiple departmental and teams and programs; inspection and regulatory support.

• Product Testing: Area focuses on techniques such as SDS-PAGE Silver, QPCR, Potency, Kinetics assay, Enzyme Activity, pH, Osmo, A280 etc., to support in-process, release and stability testing.

• May refer to established precedents and policies.

What you bring to Takeda:

• Typically requires a bachelor's degree and a minimum of 5+ years of related experience. (science related degree would be ideal).

• Previous experience in a GMP QC role would be ideal.

• Main Skills: Microsoft Office, Laboratory Information Management System, SAP, Trackwise , 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. In this role, you may:

• May be required to 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.

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

• Ability to work around chemicals (if working around the laboratories).

• Ability to wear personal protective equipment such as gloves, gowning, and respiratory protection in some cases.

• Ability to walk and stand for periods of time.

• Individual may be required to 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.

• 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.

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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:

$67,900.00 - $106,700.00

The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job.The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.

U.S. based employees may be eligible for short-term and/or long-termincentives. U.S.based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S.based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.

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.

LocationsUSA - MA - Lexington - BIO OPSWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull time