Quality Associate II
- Employer
- Takeda
- Location
- Round Lake, Illinois
- Start date
- Jun 2, 2023
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- Discipline
- Quality, Quality Control
- Required Education
- Bachelors Degree
- Position Type
- Full time
- Hotbed
- Best Places to Work
Job Details
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Job DescriptionAbout the role:The Quality Associate II - Deviation and CAPA 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 electronic deviation and CAPA system and for the deviation and CAPA process. Your secondary responsibilities will be to support other quality system processes including change control management, document control, and validations. You will support projects aimed at improving deviation and CAPA management processes at the Round Lake facility, including launches of and changes to electronic systems. This support may include computer system validation activities (e.g., execution of test cases) or training of users. You will report to the Associate Director of Quality Systems.
How you will contribute:- Manage Standard Operating Procedures and other Quality System Documentation relevant to your responsibilities/expertise. Monitor activities/prepares metrics related to area of responsibility/expertise and escalates issues. Collaborate with personnel to improve Quality System processes.
- Develop, approves, and delivers training materials relevant to their area of expertise.
- Assist personnel with validation-related documentation, as assigned.
- Assist personnel with document control related activities, as assigned.
- Own investigations and CAPAs and approves investigations and CAPAs pertinent to all areas of the plant.
- Experience in utilization of electronic systems such as TrackWise.
- Working knowledge of descriptive statistics preferred.
- Typically requires bachelors' degree in science, engineering, or another related technical field.
- 2+ years of related work experience.
- 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
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:
- In general, the position requires 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.
- Must be able to work non-traditional work hours or work extended hours, including weekends and holidays, to support a 24/7 manufacturing operation as needed.
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.
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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 DeliveryWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull timeCompany
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
- Website
- https://www.takeda.com/
- Location
-
650 East Kendall Street
Cambridge
MA
02421
United States
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