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Job Description

About the role:

The Sr. Quality Assurance Specialist is part of the Quality Compliance Organization at Takeda's Round Lake aseptic pharmaceutical manufacturing facility and will report to the Associate Director, Head of Quality Compliance.

You will be the Supplier Quality representative including execution of and oversight over all relevant supplier quality processes.  You will work as part of a team providing quality oversight, help the site maintain inspection readiness, and promote adherence and resolve issues related to GMP and Compliance.  

Responsibilities include providing solutions and improving programs related to different site processes. You will work with quality, manufacturing, and technical support groups to resolve issues related to Quality Compliance, provide solutions and improve programs for compliance to internal/external quality and customer requirements.

How you will contribute:

• Compliance: Complete local self-inspection audits including scheduling, facilitation, inspection, and observation response approval. Compile and review several important quality indicator trends/metric data at defined frequencies or upon request. Monitor Inspection Management Systems records for adherence to global requirements. Identify potential concerns and recommend when escalation is needed. Provide guidance and author content to support regulatory submissions. Conduct gap assessments of internal quality and compliance systems, using applicable quality manual, quality standards, global and local procedures, applicable country regulations, directives, inspection guidelines and compendia to ensure site is in compliance. Track, trend and report out metrics in applicable areas
• Quality Systems: Own Standard Operating Procedures and other Quality System Documentation relevant to their responsibilities/expertise.  Monitor activities/prepare metrics related to responsibilities/expertise and escalate issues.  Collaborate with personnel to improve Quality System processes.  Approve relevant SOPs/documents.
• Training: Develops, approves, and delivers training materials relevant to their area of expertise.
• Supplier Quality: Acts as a Lead Auditor for supplier qualification activities. 
• Validation Quality: Assists personnel with validation-related documentation, as assigned.
• Deviations and CAPA: Own investigations and CAPAs relevant to area/expertise.  Approves investigations and CAPAs important to all areas of the plant.
• Change Control: Owns and approves change controls relevant to area/expertise.
• Risk Management: Leads teams in the execution of risk management activities. Lead the Risk Register and Site Risk Gap Program and provide support to mitigation plans.
• Quality Leadership: Leads Quality project teams and present to Plant management project plans, progress, and risks.  Represent us in areas of expertise to governmental Regulatory bodies.
• Must be proficient in written and oral English.
• Can guide decisions based on regulatory knowledge and have experience presenting to inspection auditors.
• Must have excellent project management experience applying cGMPs.
• Can work as a collaborative team member and in some cases lead a small team.
• Must demonstrate and understand complex manufacturing processes. Can identify, escalate and resolve potential compliance and safety issues.
• Experience in use of electronic systems such as TrackWise and proficient Microsoft Office (Word, Excel, PowerPoint) skills. 
• Working knowledge of descriptive statistics.
• Complete assigned training on time. 

Minimum Requirements/Qualifications:

• Required:
  • Typically requires bachelors' degree in science, engineering or other related technical field.
  • 4+ years of related experience (regulatory/audit experience).
• Desired:
  • External Auditor Certification (e.g. ASQ Certified)

What Takeda can offer you:

• 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

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, your work will be a combination of sedentary work and walking around observing conditions of the facility.
• Can conduct work in an office and virtual environment.
• Facilitate virtual training.
• 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 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.
• You must not be allergic to Cephalosporin drugs.
• May be exposed to and must not be allergic to cephalosporin. (Applies only to product touch roles – remove for all other roles)
• Must be able to work non-traditional work hours or work extended hours, including weekends and holidays, as needed. 

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