Quality Control Senior Analyst I

Bio-Life Plasma, LLC

Lexington, MA

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Job Description

Job Title: Quality Control Senior Analyst I

Location: Lexington, MA

About the role:

Job Summary/Operations Involvement:

In this position, you will focus on the daily lab operations and execution of testing to support manufacturing operations/validation or development studies. Testing may include but not limited to samples from drug substance/product and various protocol studies using test methods derived from the various compendia and non-compendial sources. This is a fully onsite role, and you will report to the Associate Director of QC.

How you will contribute:
  • Testing execution, participate in training analysts, trouble shooting of methods.
  • QC operations support which requires data review, data trending, OE/5S/LEAN initiatives, maintenance of equipment and reagents, lab house keeping, support for other QC groups. Compliance and quality systems (SOP revisions, input to quality systems records).
  • Involvement in various departmental and cross-functional teams and initiatives; inspection and regulatory support.
  • Product testing: Areas of focus on techniques such as qPCR, SDS-PAGE Silver, Potency and Compendial.
What you bring to Takeda:
  • Bachelor's degree and 10+ years of related experience.
  • Experience using pipettes
What Takeda can offer you:
  • Comprehensive Healthcare: Medical, Dental, and Vision
  • Financial Planning & Stability: 401(k) with company match and Annual Retirement Contribution Plan
  • 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 and company match of charitable contributions
  • Family Planning Support
  • Professional training and development opportunities
  • Tuition reimbursement
Important Considerations

At Takeda, our patients rely on us to deliver quality products. As a result, we must follow strict rules in our manufacturing facilities to ensure we are not endangering the quality of the product. In this role, you may:

  • Limited to no travel expected. Travel between sites is required.
  • The following physical abilities are required in order to fulfill the job duties.
  • Repetitive bending and reaching to setup and break-down equipment (if required by specific activity).
  • Ability to work around chemicals (if working around the laboratories).
  • Ability to walk and stand for periods of time.
  • Individual may be required to participate in environmental chamber monitoring program which would include the use of an on-call mobile phone as well as on-site support during non-business hours.
  • May work in a controlled environment requiring special gowning and wear protective clothing over the head, face, hands, feet and body. This may include additional hearing protection for loud areas.
  • Will need to remove all make-up, jewelry, contact lenses, nail polish and/or artificial fingernails while in the manufacturing environment.
  • May work in a cold, hot or wet environment.
  • May work around chemicals such as alcohol, acids, buffers and Celite that may require respiratory protection.
More about us:

At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.

Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

This posting excludes Colorado applicants.



EEO Statement

Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.

USA - MA - Lexington - BIO OPS
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Full time ID:uDnQdo