Senior Quality Analyst Quality Systems

Job Description

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Job Description

About the Role:

You will support Quality Management System Activities, which includes update and maintenance of associated tasks within QMS system for Supplier Management, Deviation and CAPA, Change Control, Document Management System and Learning Management Systems. Compile data and reports to support Quality Council and goals and maintain appropriate records and management of the electronic records. You will report to the Manager of Quality.

How you will contribute:

• Support Deviations and Change Controls helping materials and suppliers
• Support revisions and updates to Quality Agreements
• Support Supplier Audits and Questionnaires
• Coordinate Supplier Notification of Changes and Supplier Action Reports
• Compile data for Supplier Monitoring for Quality Council and other reporting mechanisms
• Complete actions as assigned within Track Wise Supplier Management System workflows
• Support and collaborate with quality, manufacturing, engineering, global and technical support groups on issues related to Supplier Quality.
• Promptly escalate and report essential material issues, supplier performance incidents to management.
• Support Gap Assessments related to Quality Management System integration.
• Support task closures for Deviations and CAPAs, as assigned
• Have knowledge of FDA, Good Data and Documentation Practices (GDDP), current Good Manufacturing Practices (cGMP)

What you bring to Takeda:

• Bachelor's degree in science, engineering or other related technical field preferred. 2+ years of related experience.
• Must be able to lift, push, pull and carry up to 20 lbs.
• In general, your work will be a combination of sedentary work, operating machinery, and equipment, and standing or walking to perform inspection and release.
• Can work in controlled environments requiring special gowning. Will follow gowning requirements and wear protective clothing over the head, face, hands, feet and body.
• No make-up, jewelry, contact lenses, nail polish or artificial fingernails may be worn in the manufacturing environment.
• Will work in a cold, wet environment
• Must be able to work multiple shifts, including weekends.
• Can work overtime
• May be asked to work in a confined area.
• Some Clean Room and cool/hot storage conditions

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

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.

Empowering our people to shine:

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.

Location and Salary Information: This post excludes CO 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.

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