Job Description

Job Title: Quality Systems Specialist III

Location: Brooklyn Park, MN

About the role:

You will be the primary Business Administrator and lead subject matter expert (SME) for Takeda’s Electronic Quality Management System (EQMS) and other applications, as they arise. This is a hybrid role that reports to the Associate Director of Quality Systems.

How you will contribute:

• Provide routine Business Administration support for the Brooklyn Park EQMS (e.g., processing of applicable Help Desk Tickets, Administration of user accounts and EQMS user roles, etc.) and monitor the EQMS for compliance with procedures, and completion of deliverables according to committed timelines.
• Participate in and lead Global EQMS initiatives related to EQMS topics (e.g., Community of Practice, workstream participation).
• Participate in internal or supplier audits as well as prepare reporting information for Change Control Review Board and Investigation Review Board
• Identify, investigate, and resolve complex technical issues using problem-solving skills. Notify management of actions taken.
• Analyze and interpret projects, studies, or investigations to determine next steps. Make decisions and notify management of action taken.
• Write new documents and revise existing documents, perform QA approval of controlled documents.
• Identify, propose, and implement Quality Process and system improvements.
• You will develop, support, and deliver training on quality management procedures and workflows (e.g., deviation, OOS, CAPA) and on department-specific procedures and systems.
• You will be responsible for routine monitoring, reporting and escalation of quality performance metrics according to established controlled procedures.
• Perform additional duties, as assigned.

What you bring to Takeda:

• BA/BS in any Life Science discipline.
• 5+ years’ experience in Regulated (food, medical device, or pharma/biotech) industry.
• Direct experience with Quality Assurance within the Life Science industry.
• Comprehensive knowledge of quality and GMP principles.

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. In this role, you 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.
• Need to remove all make-up, jewelry, contact lenses, nail polish and/or artificial fingernails while in the manufacturing environment.
• Work in a cold, wet environment.
• Work multiple shifts, including weekends, or be asked to work supplemental hours, as necessary.
• Work around chemicals such as alcohol, acids, buffers and Celite that may require respiratory protection.
• In general, the position requires mostly sedentary work with occasionally walking throughout the facility.
• Wrist and hand motion (e.g., typing, writing) while operating office equipment such as computer, phone, calculator, etc.
• Travel to various meetings or client sites, including overnight trips.
• Requires approximately 0-5% travel.

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.

This posting excludes Colorado applicants.

#GMSGQ #ZR1 #LI-MA1

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

Brooklyn Park, MN

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

How to Apply

Job Categories: Equal Opportunities. Job Types: Full-Time. Job Tags: cGMP, quality, and quality systems. Salaries: 60,000 - 80,000.

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