Quality Specialist III

Takeda•Brooklyn Park, MN

1d•$89,900 - $141,240•Onsite

About The Position

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.

Requirements

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.
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.

Nice To Haves

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
Experience with Electronic Quality systems (e.g. SAP, PAS-X, TrackWise)
Certified Quality Auditor (CQA) or other ASQ certifications

Responsibilities

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.
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.