Are you looking for a patient-focused company that will inspire you and support your career? If so, be empowered to take charge of your future at Takeda. Join us as a Quality Systems Specialist II in our Brooklyn Park, Minnesota office.
Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As a Quality Systems Specialist II working on the Quality team, you will be empowered to serve as subject matter expert (SME) for our Electronic Quality Management System (EQMS) and support other Quality Systems, and a typical day will include:
- Serve as the primary Business Administrator and subject matter expert (SME) for Takeda's Electronic Quality Management System (EQMS) and other applications, as they arise.
- Support quality management procedures and provide targeted technical training (e.g., deviation, CAPA, change management).
- Support other Quality Systems areas as needed.
- This position is responsible for routine monitoring, reporting and escalation of quality performance metrics according to established controlled procedures.
- 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.).
- Routinely monitors the EQMS for compliance with procedures, and completion of deliverables according to committed timelines. Track progress against baseline metrics.
- Completes work thoroughly, with a high attention to detail, using working knowledge of quality concepts and internal procedures and controls.
- Analyzes and interprets projects, studies, or investigations to determine next steps in consultation with Supervisor. Makes basic decisions independently. Reviews more complex decisions with management.
- Identifies and resolves basic technical issues using problem-solving skills, in consultation with Supervisor.
- Assesses deviations assigned a direct root cause, defined CAPAs, and entry-level change controls
- Revises department-specific controlled documents, independently.
- Receives minimal supervision on routine work assignments. Receives specific instruction on new work.
- Participates in required training and keeps training files current.
- Identifies and proposes Quality Process and system improvements.
- Performs additional duties, as assigned.
EDUCATION, EXPERIENCE, BEHAVIORAL COMPETENCIES AND SKILLS:
BA/BS (or Master's) in any Life Science discipline preferred, and/or 3-5 years (0-2 with Master's) experience in Regulated (food, medical device, or pharmaceutical/biotech) industry.
- Understands and applies good working knowledge of quality and GMP principles.
- 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
WHAT TAKEDA CAN OFFER YOU:
- 401(k) with company match and Annual Retirement Contribution Plan
- Tuition reimbursement
- Company match of charitable contributions
- 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
Empowering Our People to Shine
Learn more at takedajobs.com.
No Phone Calls or Recruiters Please.
Brooklyn Park, MN