Takeda Quality Systems Specialist You will be the primary Business Administrator and lead subject matter expert (SME) for Takeda’s Electronic Quality Management System (EQMS) and other applications, as they arise. This is a hybrid role that reports to the Associate Director of Quality Systems.
Job Title: Quality Systems Specialist III
Location Brooklyn Park, Minnesota
What you bring to Takeda:
- BA/BS in any Life Science discipline.
- 5+ years’ experience in Regulated (food, medical device, or pharma/biotech) industry.
- Direct experience with Quality Assurance within the Life Science industry.
- Comprehensive knowledge of quality and GMP principles.
What Takeda can offer you:
- Comprehensive Healthcare: Medical, Dental, and Vision.
- Financial Planning & Stability: 401(k) with company match and Annual Retirement Contribution Plan.
- Health & Wellness programs including onsite flu shots and health screenings.
- Generous time off for vacation and the option to purchase additional vacation days.
- Community Outreach Programs and company match of charitable contributions.
- Family Planning Support.
- Professional training and development opportunities.
- Tuition reimbursement.
How you will contribute:
- Provide routine Business Administration support for the Brooklyn Park EQMS (e.g., processing of applicable Help Desk Tickets, Administration of user accounts and EQMS user roles, etc.) and monitor the EQMS for compliance with procedures, and completion of deliverables according to committed timelines.
- Participate in and lead Global EQMS initiatives related to EQMS topics (e.g., Community of Practice, workstream participation).
- Participate in internal or supplier audits as well as prepare reporting information for Change Control Review Board and Investigation Review Board
- Identify, investigate, and resolve complex technical issues using problem-solving skills. Notify management of actions taken.
- Analyze and interpret projects, studies, or investigations to determine next steps. Make decisions and notify management of action taken.
- Write new documents and revise existing documents, perform QA approval of controlled documents.
- Identify, propose, and implement Quality Process and system improvements.
- You will develop, support, and deliver training on quality management procedures and workflows (e.g., deviation, OOS, CAPA) and on department-specific procedures and systems.
- You will be responsible for routine monitoring, reporting and escalation of quality performance metrics according to established controlled procedures.
- Perform additional duties, as assigned.
Takeda Quality Systems Specialist
