Posted to MedZilla on 5/20/2018


Takeda Pharmaceuticals

US-MA, Quality Control Analyst R0001730-MZ


 
 

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Job Description

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 Control Analyst in our Cambridge office.

Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As a Quality Control Analyst working on the Analytical Development, Small Molecules team, you will be empowered work on teams across Analytical Development and interact with external stakeholders, and a typical day will include:

POSITION OBJECTIVES:

Responsible for executing basic/routine data review/analysis, supports GxP documentation work and performs unit operations under supervision. This position also assists in the planning of basic unit operations, performs stability coordination, initiates OOS/ATI/Investigations, and liaisons with vendor test laboratories.

POSITION ACCOUNTABILITIES:

  • Works with department peers to execute well defined assignments.
  • Prepares protocols/reports as appropriate/necessary
  • Interprets data with support from supervisor, and contributes to technical reports and regulatory filings
  • Identifies and communicates routine technical problems and data and vendor issues within scope of responsibility
  • Supports project team and local initiatives as appropriate
  • Makes and understands basic decisions within scope of responsibility.
  • Assists with method transfer and method validations at vendors as appropriate
  • Build studies/enters data into validated data repository
  • Facilitates document support for a validated document storage system
  • Coordinates with departmental peers on project work as appropriate
  • Reviews QC testing data of small molecule and/or Biologics analytical methods generated by vendor test labs. Initiates vendor OOS/ATI/Investigations, verifies that data meets current specifications, generates COA(s), and tracks cycle time metrics, captures related deviations, OOS, CAPAs, atypical results and change controls
  • Trends reference standards and data

EDUCATION, EXPERIENCE, BEHAVIOURAL COMPETENCIES AND SKILLS:

Education and Experience:

Required:

  • Associates degree in Chemistry, Biology or equivalent with 2+ years relevant industry experience
  • Bachelor degree in Chemistry, Biology or equivalent with some relevant industry experience
  • Previous experience in Quality Control and/or Analytical Development preferred

Knowledge and Skills:

  • Analytical and Problem Solving Skills -Able to troubleshoot routine issues or problems using appropriate information
  • Teamwork - Ability to work well within small group functional teams.
  • Communication Skills -Ability to expresses one s self clearly and concisely within function; documents issues and/or concerns concisely; timely and effectively communicates issues to supervisor
  • Organization Exercises good time management skills
  • Working knowledge of GMP compliance

TRAVEL REQUIREMENTS:

  • May require approximately 5% travel.

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.

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Please visit our website at takedajobs.com

 
 


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