By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use.  I further attest that all information I submit in my employment application is true to the best of my knowledge.

Job Description

About the role:

Perform Quality activities associated with cGMP biologics, intermediate, and/or drug substance manufactured at the Takeda Brooklyn Park Site. Focused primarily on providing support and guidance on complex and non-routine quality-related issues

How you will contribute:

• Follow all established, written procedures. Drive the assessment and implementation of global and local policies, guidance documents, standards, and procedures governing cGMP work performed at the site.
• Performs documentation review 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.
• Actively engage with the local team to prioritize and complete activities to support the site goals.
• Review/approve document workflows, low/medium-risk Deviations, CAPAs, and Level 1 and 2 Change Controls.
• Investigate/own quality events (deviations, CAPAs, and Level 1 or 2 Change Controls) for quality-related topics.
• Writes new documents and revises existing documents, independently.
• Develops and provides training on department-specific procedures and systems. Trains and mentors’ peers.
• Contribute to and share best practices in global engagement activities (community of practice) for quality related topics.
• Drive a Continuous Improvement mindset to identify and propose Quality Process and system improvements to meet department/site KPIs.
• Makes informed, data-based decisions utilizing a risk-based approach.
• Complete mandatory training within required timeframe.
• Performs additional duties, as assigned.
• Employee at this level is involved in routine and non-routine tasks of complex scope.
• Employee executes on new work and refers to policies and procedures for guidance.
• Responsible for conducting independent work with minimal guidance from trainers and more senior staff.
• Responsible for contributing to moderate scope decisions founded on GxP principles, local/global procedures, robust scientific basis, and utilizing the concepts of PTRB (Patient-Trust-Reputation-Business).
• Cross-functional key collaborator to achieve site goals.

What you bring to Takeda:

• BA/BS (or Master's) in any Life Science discipline preferred, and/or 5+ years’ experience in Regulated (food, medical device, or pharma/biotech) industry.
• Must have direct experience with quality in a regulated industry.
• Understands and applies comprehensive knowledge of quality and GMP principles.
• Experience with the following is preferred: Basic statistics; Internal / External Auditing; Change management, Peer review/approval of documentation; Quality Training; Quality Improvement Tools (Risk Assessments, flowcharts, root cause analysis); Supplier Quality; Technical Writing and Review; Writing/reviewing/approving investigations; Monitor and report KPIs.
• Ability to perform 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 and drive issue resolution.
• 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, teach, and continuously improve.
• Positive work attitude that supports teamwork and continuous improvement.
• Quality Assurance – Proficient knowledge of manufacturing and/or lab processes, batch record review, batch disposition, material hold, change management and document workflows, and Quality on the Shop Floor. Proficient knowledge in the management of the Deviation/CAPA/Change Control systems and document workflows
• Must be experienced in Microsoft Office applications, especially Word, Excel, and PowerPoint.
• Experience with Electronic Quality systems (e.g. SAP, PAS-X, TrackWise), preferred
• Certified Quality Auditor (CQA) or other ASQ certificat