Posted to MedZilla on 9/22/2019


Takeda Pharmaceuticals

US-MN, Quality Assurance Specialist I/II (2nd shift) R0010990-MZ


 
 

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Job Description

OBJECTIVES:

  • Perform Quality Assurance activities associated with commercial cGMP biologics drug substance manufactured at the Brooklyn Park site of Takeda.
  • Responsible for review of batch records and associated documentation in support of timely commercial drug substance batch disposition.
  • Provides assistance to site personnel performing deviation investigations, CAPAs, and change controls.
  • Focused primarily on providing support and guidance on non-complex and routine quality-related issues.

ACCOUNTABILITIES:

  • Performs documentation review thoroughly, with a high attention to detail, using working knowledge of quality concepts and internal procedures and controls.
  • Supports GMP compliance with time spent in the Manufacturing environment on a regular basis.
  • Administrates QA Operations systems in support of GMP manufacturing activities; material hold, equipment out of service, etc.
  • Identifies and resolves basic technical issues using problem-solving skills, in consultation with management.
  • Supports deviations assigned a direct root cause, defined CAPAs, and entry-level change controls.
  • Revises and reviews department-specific controlled documents independently.
  • Receives minimal supervision on routine work assignments. Receives specific instruction on new assignments.
  • Identifies and proposes Quality Process and system improvements.
  • Complete mandatory training within required timeframe.
  • Performs additional duties, as assigned, including support of QA Compliance Review, Quality Compliance, and Supplier Quality functions.

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:

BA/BS (or Master's) in any Life Science discipline preferred, and/or 3-5 years 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.

LICENSES/CERTIFICATIONS:

  • NA

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.

OTHER REQUIREMENTS:

  • May be required to wear personal protective equipment (PPE) and other clean room garments daily. This may include: safety shoes, safety glasses, aprons, face shields, lab coats, full body gowns, hair nets and gloves and hearing protection.
  • May be required to participate in an on-call rotation for off-shift coverage or occasionally work off-shift hours to help support a 24-7 manufacturing department.
  • Willingness to travel to various meetings or training, this could include overnight trips.
  • Requires approximately 5% travel.

Locations

Brooklyn Park, MN

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time


Please visit our website at takedajobs.com

 
 


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