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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.
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.
