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