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:
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.
- 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:
- 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
- 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.