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Quality Systems Specialist II

応募後で応募 求人ID R0022655 掲載日 09/07/2020 Location:Brooklyn Park, Minnesota

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Job Description

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:

OBJECTIVE:

  • 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.

ACCOUNTABILITIES:

  • 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.


PHYSICAL DEMANDS:

  • 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.

Locations

Brooklyn Park, MN

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

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