QC Analyst II - Bio Chemistry

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Job Description

Job Title: QC Analyst II

Location: Lexington, MA

About the role:

Primary duties of this position will focus on the daily lab operations and execution of testing to support manufacturing operations. This position is expected to maintain operational and GMP readiness of the QC areas.In addition, this position will participate in more complex projects, Operational excellence initiatives and various quality systems.

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 but not limited to samples from drug substance and drug product, manufacturing, stability, raw materials and various protocol studies using test methods.

• In addition, this position will participate in more complex projects, Operational excellence initiatives and various quality systems.

• Biochemistry Focus: A280, SOLO A280, Compedia methods (pH. Moisture, OSMO, Appearance, Subvisible particles), Enzyme Actitity assays, DNA, PCR, Free Thiol

• Testing execution

• QC operations support which entails data review, data trending, OE/5S initiative, maintenance of equipment and reagents, reagent prep, lab house keeping, support for other QC groups if needed.

• Compliance and quality systems (SOP revisions, input to quality system 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 of data from which answers can be readily obtained.Builds stable working relationships internally.

What you bring to Takeda:

• Bachelors degree and minimum of 2-5 years related experience

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

• Excellent communication, interpersonal and organizational skills

• Ability to work well both independently and in a team environment

• ​Ability to prioritize work and multitask.

• Previous experience in a GMP QC role is preferred

• MS Office, LIMS, SAP, Trackwise, EDMS, Compliance and strong 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.

• Need to remove all make-up, jewelry, contact lenses, nail polish and/or artificial fingernails while in the manufacturing environment.

• Repetitive bending and reaching to setup and break down equipment

• 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.

• 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.

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 #LI-Onsite

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.

Locations

USA - MA - Lexington - BIO OPS

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time