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Quality Associate II

Employer
Takeda
Location
Round Lake Beach, Illinois
Start date
Apr 9, 2024

View more

Discipline
Quality, Quality Control
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
Best Places to Work

Job Details

By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’sPrivacy Noticeand Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.

Job Description

Job Title: Quality Associate II

Location: Round Lake, IL

About the role:

The Quality Associate II - Change Control is in the Quality Systems organization at the Takeda Round Lake aseptic pharmaceutical manufacturing facility. Your primary responsibility will be to serve as the administrator for the site's change control process, electronic change control system, and change review board. Your secondary responsibilities will be to support other quality system processes including change deviation/CAPA management, document control, and validations. You will support projects aimed at improving change control processes at the Round Lake facility.

How you will contribute:
  • Owns Standard Operating Procedures and other Quality System Documentation relevant to their responsibilities/expertise. Monitor activities/prepares metrics related to responsibilities/expertise and escalates issues and appropriate. Collaborate with cross-functional personnel to improve Quality System processes.

  • Approve SOPs/documents of responsibilities/expertise.

  • Develop, approves, and deliver training materials relevant to their area of expertise.

  • Deploy global projects such as process and electronic system changes to users locally.

  • Assist personnel with validation-related documentation, as assigned.

  • Assist personnel with document control related activities, as assigned.

  • Manage deviations and CAPAs and approves deviations and CAPAs relevant to all areas of the plant.

  • Manage and approve change controls relevant to all areas of the plant.

  • Lead Quality project teams and presents project plans, progress, and risks to plant management.

  • Represent us in areas of expertise to governmental regulatory bodies.

  • Identify, escalate, and resolve potential compliance and safety issues.

  • Must be proficient in written and oral English.

  • Experience applying cGMPs.

  • Will work as a collaborative team member and in some cases lead a small team.

  • Experience presenting to inspection auditors.

  • Experience in use of electronic systems such as TrackWise..

  • Fluency in Mandarin a plus.

What you bring to Takeda:
  • Requires bachelors' degree in science, engineering or other related technical field and 2+ years of related experience.

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. You may:

  • In general, you will do a combination of sedentary work and walking around observing conditions of the facility.

  • Must be able to stand and/or walk for an extended period over an 8–12-hour shift between rooms and across the site.

  • Indoor working conditions.

  • Will work around moving equipment and machinery.

  • 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.

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

  • May work in a cold, hot or wet environment.

  • May work around chemicals such as alcohol, acids, buffers and Celite that may require respiratory protection.

  • Can work on multiple shifts, including weekends, to support a 24/7 manufacturing operation as needed.

More about us:

At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and the best patient support programs. Takeda is a patient-focused company to 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

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 - IL - Round Lake - Drug Delivery

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 - IL - Round Lake - Drug Delivery

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

Company

Takeda is a global, values-based, R&D-driven biopharmaceutical leader headquartered in Japan, committed to discover and deliver life-transforming treatments, guided by our commitment to patients, our people and the planet. Takeda focuses its R&D efforts on four therapeutic areas: Oncology, Rare Genetics and Hematology, Neuroscience, and Gastroenterology (GI). We also make targeted R&D investments in Plasma-Derived Therapies and Vaccines. We are focusing on developing highly innovative medicines that contribute to making a difference in people’s lives by advancing the frontier of new treatment options and leveraging our enhanced collaborative R&D engine and capabilities to create a robust, modality-diverse pipeline. Our employees are committed to improving quality of life for patients and to working with our partners in health care in approximately 80 countries and regions.

For more information, visit https://www.takeda.com.

Stock Symbol: TAK

Company info
Website
Location
650 East Kendall Street
Cambridge
MA
02421
US

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