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Quality Assurance Specialist III - Brooklyn Park, MN

 

Takeda Pharmaceuticals

 

 

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 Assurance Specialist III in our Brooklyn Park, MN office.

At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

Here, you will be a vital contributor to our inspiring, bold mission.

As a Quality Assurance Specialist III working on the Quality Assurance team, you will be empowered to help increase quality and service by helping to reduce costs. In this role, you will contribute to Takeda’s mission by helping to build a better tomorrow for our patients and their families. A typical day will include:

POSITION OBJECTIVES:

  • Perform Quality Assurance activities associated with commercial cGMP biologics drug substance manufactured at the Brooklyn Park site of Takeda.
  • Responsible for review of documentation in support of commercial drug substance manufacturing.
  • Provides guidance to site personnel performing deviation investigations, CAPAs, and change controls through knowledge of quality concepts, investigational techniques, and root cause analysis.
  • Focused primarily on providing support, guidance, and training on complex and non-routine quality-related issues.

POSITION ACCOUNTABILITIES:

  • Performs documentation review thoroughly, with a high attention to detail, using extensive working knowledge of quality concepts and internal procedures and controls.
  • Supports GMP compliance with time spent in the Manufacturing environment on a regular basis.
  • Analyzes and interprets projects, studies, or investigations to determine next steps. Makes decisions independently and notifies management of action taken.
  • Identifies, investigates, and resolves complex technical issues using problem-solving skills. Notifies management of actions taken.
  • Reviews deviations, investigations, and CAPAs associated with cGMP compliance. Supports change controls related to Quality topics.
  • Writes new documents and revises existing documents, independently.
  • Performs QA review/approval of controlled documents.
  • Receives minimal supervision on work assignments. Receives overall project direction from management, but completes most work independently.
  • Develops and provides training on department-specific procedures and systems. Trains and mentors peers.
  • Identifies and proposes Quality Process and system improvements.
  • Participates in internal or supplier audits as needed.
  • Complete mandatory training within required timeframe.
  • Performs additional duties, as assigned, including support of QA Operations, Quality Compliance, and Supplier Quality functions.

EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS:

  • BA/BS (or Master's) in any Life Science discipline preferred, and/or 5+ years experience in Regulated (food, medical device, or pharma/biotech) industry.
  • Must have direct experience with Quality Assurance within the Life Science industry.
  • Understands and applies comprehensive knowledge of quality and GMP principles. Maintains current understanding of global GMP regulations.
  • 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.
  • 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.

TRAVEL REQUIREMENTS:

  • Willingness to travel up to 5% to various meetings or training, this could include overnight trips.

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.

ADDITIONAL INFORMATION:

  • Familiarity or experience with the following is preferred: Auditing; basic statistics; Certified Quality Auditor (CQA); Internal / External Auditing; Peer review/approval of documentation; Quality Training; Quality Improvement Tools (Risk Assessments, flowcharts, root cause analysis); Supplier Quality; Technical Writing and Review; Writing/reviewing/approving investigations

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

Discover more at takedajobs.com

No Phone Calls or Recruiters Please.

#LI - SS

Locations

Brooklyn Park, MN

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

Job ID R0024236

 

 

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