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Quality Associate I - QA Ops (Second Shift)

Employer
Takeda
Location
Round Lake Beach, Illinois
Start date
Nov 26, 2024
View more categoriesView less categories
Discipline
Quality, Quality Assurance, 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

About the role:

The primary responsibility is working on Materials release and approval of completed documentation for batch folders following GMP/GDP. You will be accountable for Quality oversight on the floor and responsible for trending of observations from floor to improve them. You will be accountable for manufacture support activities on the floor, revising SOPs and forms, and developing training. You will be a second shift role Monday - Friday from 4:00 PM - Midnight.

How you will contribute:

  • Responsible for raw material and bulk container receipts, release, and investigation if any issues found. Follow-up with appropriate Takeda facilities for documentation correction in.
  • Manufacturing support activities including batch record documentation, issuance of Batch record, approval of OSI PI Reports, scanner card delivery of test and stability samples, label copy control and issuance, raw material release, in-process work order release, and retain sample management.
  • Responsible for oversight of quality line operations concerning product quality and conformance to regulations and Takeda quality procedures.
  • Quality Approval of labeling artwork and specifications for packaging material using appropriate artwork management software.
  • Identify and assess quality risk in production operations daily. TIQ/QOTSF review of checklists and trending of observations for monthly quality council. Responsible for TIQ/QOTSF program management.
  • Develop training materials and procedures and participation on teams to implement process improvements. Be a Subject Matter Expert (SME) and provide training to employees needed on relevant areas.
  • Demonstrate effectiveness in task completion and empowerment of others, deviation/nonconformance management, training, and problem solving
  • Complete interfacility impact assessments for product/process changes.
  • Manage investigations, close deviations, assignment of proper corrective actions, and facilitate implementation for Manufacturing under the direction of Compliance Management.
  • Participate in internal and external regulatory audits and present to auditor.

What you bring to Takeda:

  • Bachelors' degree in science, engineering, or other related technical field. Some related experience.
  • Knowledge of the local and international regulatory environment and regulations for manufacture of biological products.
  • You must not be allergic to Cephalosporin drugs.
  • Ability to walk 1-3 miles and lift 10 lbs

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:

  • May 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 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.
  • 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 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:

56,000.00 - 88,000.00

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 - IL - Round Lake - Drug Delivery

Worker TypeEmployee

Worker Sub-TypeRegular

Time TypeFull time

Job Exempt

Yes

Company

For over 240 years, Takeda’s propensity to evolve has driven the next generation of innovation. Today, our organization spans the globe—colleagues across business units and functions face challenges head-on to deliver life-transforming treatments, guided by our commitment to patients, our people and the planet.

As a values-based, R&D-driven biopharmaceutical leader headquartered in Japan, we focus our 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. In addition to our R&D efforts, we’re laser-focused on harnessing the power of data, digital, and technology to improve health outcomes for patients across the globe.

 

Since our founding in Japan, integrity and putting patients first have been at the heart of our identity. We're proud of our employees and their commitment to improving the quality of life for patients, and to working with our partners in health care in approximately 80 countries and regions. With each new breakthrough comes opportunities to develop your career, hone new skills, and create a brighter future

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

Company info
Website
Location
650 East Kendall Street
Cambridge
MA
02421
United States

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