Posted to MedZilla on 3/25/2017


Takeda Pharmaceuticals

US-MN, Sr. Quality Assurance Specialist - Supplier Quality 1700276-MZ


 
 

OBJECTIVES:
  • 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.

ACCOUNTABILITIES:

This individual:
  • 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 nonconformances. 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.
  • Provides support, guidance, and training on complex and non-routine quality-related issues.
  • 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.
  • Identifies, investigates, and resolves complex technical issues using problem-solving skills. Notifies management of actions taken.
  • Leads investigation teams and ensures proper close out and follow up.
  • 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.
  • Identifies, proposes, and implements Quality Process and system improvements.
  • Performs additional duties, as assigned.
Qualifications

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:

BA/BS (or Master's) in any Life Science discipline preferred, and/or 8+ years (5+ with Masters) experience in Regulated (food, medical device, or pharma/biotech) industry.
  • Must have direct experience with Quality Assurance within the Life Science industry.
  • Understands and applies comprehensive knowledge of quality and GMP principles. Maintains current understanding of global GMP regulations.
  • Ability to handle multiple tasks concurrently and in a timely fashion.
  • Good interpersonal skills and ability to work effectively and efficiently in a team environment to accomplish goals.
  • Excellent verbal and written communication skills and ability to communicate effectively with site personnel, peers and management.
  • Must be able to read, write and converse in English.
  • Must display eagerness to learn and continuously improve.
  • Positive work attitude that supports teamwork and continuous improvement.
  • Must have the following personal attributes: integrity and trust, work ethic, sound judgment, intellectual honesty, pragmatism, courage and conviction.
  • Must be experienced in Microsoft Office applications, especially Word, Excel and PowerPoint.

PHYSICAL DEMANDS:

  • Wrist and hand motion (e.g. typing, writing)
TRAVEL REQUIREMENTS:
  • Willingness to travel to various meetings or client sites, including overnight trips
  • Requires approximately 25% travel



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Takeda is an EEO employer of minorities, women, disabled, protected veterans. For more information, visithttp://www.takeda.us/careers/EEO_Policy_Statement.aspx

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Schedule

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