Quality Systems Specialist II応募後で応募 求人ID R0022655 掲載日 09/07/2020 Location:Brooklyn Park, Minnesota
Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as a Quality Systems Specialist IIin our Brooklyn Park, MN office.
Here, you will be a vital contributor to our inspiring, bold mission.
As a Quality Systems Specialist IIworking on the Quality team, 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, KNOWLEDGE 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 pharma/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.
- Stand or sit -> Must be able to remain in a stationary or standing position for extended periods of time.
- Wrist and hand motion (e.g. typing, writing)
- Must be able to work in controlled or clean room environments requiring special gowning.
Brooklyn Park, MN