US-MN, Sr. Quality Specialist R0009405-MZ
Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as a Senior Quality Systems Specialist in our Brooklyn Park, MN office.
At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.
Here, you will be a vital contributor to our inspiring, bold mission.
As a Senior Quality Systems Specialist working on the Quality Assurance team, you will be empowered to implement and maintain procedures related to suppliers and their quality systems. In this role, you will contribute to Takeda s mission by ensure compliance with internal and regulatory requirements. A typical day will include:
Responsible for the Supplier Quality activities associated with commercial cGMP operations at the Brooklyn Park site of Takeda.
Supports the tasks related to supplier qualification and supplier quality management to assure that quality requirements are understood and fulfilled by Takeda Brooklyn Park suppliers.
Provides expertise and guidance in interpreting governmental regulations, agency guidelines and internal policies related to quality systems operations.
Support and/or represent the Quality Assurance functional area as a subject matter expert (SME) during regulatory and third- party inspections.
Leads or participates in supplier audits and collecting data, performs calculations, and reports on supplier performance metrics.
Performs reviews with suppliers on their changes and non-conformances. Works with suppliers to identify root cause and ensure implementation of Corrective and Preventive Actions.
Drives supplier selection through robust qualification processes to ensure compliance with internal and regulatory requirements.
Implements and maintains procedures/quality agreements and processes related to suppliers, their quality systems, and integration of their quality records into Brooklyn Park s QMS.
Completes work thoroughly, with a high attention to detail, using extensive working knowledge of quality concepts and internal procedures and controls.
Analyzes and interprets projects, studies, or investigations to determine next steps. Makes decisions independently and notifies management of action taken.
May review deviations, investigations, and CAPAs associated with supplier cGMP compliance. Initiates, monitors, and reviews/approves change controls related to supplier quality.
Represents Quality on cross-functional project teams.
Performs Quality review/approval of controlled documents as applicable.
Receives minimal supervision on work assignments. Receives overall project direction from management, but completes most work independently. Consults with management at the start and end of assignments.
Participates in required training and completes training according to plan.
Develops and provides training on department-specific procedures/systems and quality-related topics from industry. Trains and mentors QSS I/II/III as applicable.
Performs additional duties, as assigned.
EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS:
WHAT TAKEDA CAN OFFER YOU:
Empowering Our People to Shine
Discover more at takedajobs.com
No Phone Calls or Recruiters Please.
Brooklyn Park, MN
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