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Quality Control Analyst II Oncology amp Biologics

Location
Cambridge, MA

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Job Description:
By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that I agree with Takeda’s Privacy Notice
, Privacy Policy
and Terms of Use
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 II in our Cambridge, MA office.
Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As a Quality Control Analyst II, working on the Quality Control team, you will be empowered to collaborate with Regulatory Affairs on preparation of submission documents, responses to questions from Health Authorities, and updates on stability and batch analysis data. Takeda is a focused on the well-being of the patient and the Quality Control team is a critical component in ensuring we meet our mission. A typical day will include:
POSITION OBJECTIVES:
The Quality Control team and QC Analyst II are responsible for providing and coordinating study executions for all late phase and/or commercial products managed by the Commercial Quality Organization.
Provide analytical support during the technology transfer and qualification of new manufacturing sites.
POSITION ACCOUNTABILITIES:
Managing contract testing sites to support testing of the IPC, release and stability samples.
Performing data review, data tracking and trending to support release and stability testing of drug products.
Supporting regulatory submissions by providing batch analysis and stability testing data.
Representing QC business processes and needs within the department and at cross functional forums.
EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS:
Bachelors or Master’s Degree in Life Sciences (chemistry or biology) with relevant laboratory coursework and 3-6 years of experience in Pharmaceutical/Biotechnology field.
Must have good understanding of a variety of analytical techniques such as HPLC, GC, CE-SDS and icIEF. Experience in cell based assays is a plus.
Must have basic understanding of laboratory instrumentation.
Excellent written and oral communication skills and proficiency in completing written reports, SOP and protocols preferred.
TRAVEL REQUIREMENTS:
Up to 15% 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.
Locations
Cambridge, MA
Worker Type
Employee
Worker Sub-Type
Regular
Time Type
Full time
Apply Now
By clicking the “Apply” button, I understand that my employment application process with Takeda will commence
and that I agree with
Takeda’s
Privacy Notice
, Privacy Policy and Terms of Use .
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 II in our Cambridge, MA office.
Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As a Quality Control Analyst II, working on the Quality Control team, you will be empowered to collaborate with Regulatory Affairs on preparation of submission documents, responses to questions from Health Authorities, and updates on stability and batch analysis data. Takeda is a focused on the well-being of the patient and the Quality Control team is a critical component in ensuring we meet our mission. A typical day will include:
POSITION OBJECTIVES: The Quality Control team and QC Analyst II are responsible for providing and coordinating study executions for all late phase and/or commercial products managed by the Commercial Quality Organization.
Provide analytical support during the technology transfer and qualification of new manufacturing sites.
POSITION ACCOUNTABILITIES: Managing contract testing sites to support testing of the IPC, release and stability samples.
Performing data review, data tracking and trending to support release and stability testing of drug products.
Supporting regulatory submissions by providing batch analysis and stability testing data.
Representing QC business processes and needs within the department and at cross functional forums.
EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS: Bachelors or Master’s Degree in Life Sciences (chemistry or biology) with relevant laboratory coursework and 3-6 years of experience in Pharmaceutical/Biotechnology field.
Must have good understanding of a variety of analytical techniques such as HPLC, GC, CE-SDS and icIEF. Experience in cell based assays is a plus.
Must have basic understanding of laboratory instrumentation.
Excellent written and oral communication skills and proficiency in completing written reports, SOP and protocols preferred.
TRAVEL REQUIREMENTS:
Up to 15% 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.
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