Quality Associate Ii Jobs

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About the role:

The Quality Associate II, reports to the Associate Direactor of Quality Compliance at the Takeda Round Lake aseptic pharmaceutical manufacturing facility. The primary responsibility will be to serve as the local Supplier Quality and Quality Complaints representative including execution of and oversight over all relevant supplier quality processes. You will support projects aimed at improving supplier quality processes at the Round Lake facility, including launches of and changes to electronic systems.

How You Will Contribute

• Execute and approve customer complaint investigations to ensure timely closure of complaints. Prepare monthly, quarterly, and annual complaint metrics/trending as required. Participate in Internal and External Inspections. Assist and coordinate the preparation of reports concerning Annual Product Review.
• Leads Quality project teams and present to Plant management project plans, progress, and risks. Represents the organization in areas of expertise to governmental Regulatory bodies. Proactively identifies, escalates, and/or resolves potential compliance and/or safety issues.
• Owns and approves change controls relevant to area of responsibility/expertise.
• Leads cross-functional teams in the execution of risk management activities.
• Be a Lead Auditor for supplier qualification activities. Manages and drafts new and revised Quality Agreements. Manage and execute all activities required to maintain qualification of current suppliers.
• Develop, approves, and deliver training materials relevant to their area of expertise. Own investigations and CAPAs relevant to area of responsibility/expertise. Approves investigations and CAPAs relevant to all areas of the plant.
• Owns Standard Operating Procedures and other Quality System Documentation relevant to their area of responsibility/expertise. Monitor activities/prepares metrics related to area of responsibility/expertise and escalates issues as required and appropriate. Collaborate with cross-functional personnel to continually improve Quality System processes. Approves SOPs/documents pertaining to area of responsibility/expertise.

Minimum Requirements/Qualifications

• External Auditor Certification (e.g. ASQ Certified) desired.
• Working knowledge of descriptive statistics.
• Experience in the application of cGMPs.
• Typically requires bachelors' degree in science, engineering or other related technical field.
• Experience in utilization of electronic systems such as TrackWise.
• Able to demonstrate excellent problem solving and critical thinking skills and understanding of complex manufacturing processes.
• 2+ years of related experience (regulatory/audit experience).

What Takeda Can Offer You

• Professional development and training opportunities
• Financial Planning & Stability: 401(k) with company match and Annual Retirement Contribution Plan
• Family Planning Support
• Tuition reimbursement
• Community Outreach Programs and company match of charitable contributions
• Generous paid time off for vacation, sick leave, and volunteering
• Comprehensive Healthcare: Medical, Dental, and Vision
• Health & Wellness programs including onsite flu shots and health screenings

Important Considerations

In This Role, You May

At Takeda, our patients rely on us to create quality products and we aim to create a safe environment for our team members. As a result, we must follow strict rules in our manufacturing facilities to ensure we are not endangering the quality of the product or putting anyone at the site in harm's way.

• Work in a cold, wet environment.
• 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.
• Need to remove all make-up, jewelry, contact lenses, nail polish and/or artificial fingernails while in the manufacturing environment.
• Work around chemicals such as alcohol, acids, buffers and Celite that may require respiratory protection.
• Work multiple shifts, including weekends, or be asked to work supplemental hours, as necessary.

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.

In accordance with the CO Equal Pay Act, Colorado Applicants Are Not Permitted to Apply.

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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.

Locations

USA - IL - Round Lake - Drug Delivery

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time