Quality Control Analyst - Cell Therapies

Company: Vertex Pharmaceuticals
Location: Cambridge
Posted on: June 25, 2022

Job Description:

Job DescriptionKey responsibilities:

• Performs Quality Control (QC) testing of Cell Therapy in-process, release and stability samples. Typical test methods performed include flow cytometry, qPCR (MycoTOOL), ELISA, cell counts, sterility (BACT), gram stain and endotoxin (LAL) testing.
• Writes edits and approves Deviations and CAPAs as required. Responsible for initiating Change Controls and completing necessary documentation
• May initiate Out of Specification (OOS) and deviation investigations as needed to address non-conformances in the lab
• Assists in tracking and trending of QC data.
• Performs technical reviews of raw data.
• Records test results and maintains raw data and accurate laboratory records.
• Performs general lab and equipment maintenance duties.
• Performs other duties as assignedKey requirements:
  • Bachelors degree in Sciences
  • 3+ years experience
  • Performs tasks with strict adherence to cGMP and cGDP principles.
  • Has an understanding of basic laboratory equipment and practices.
  • Is proficient in the use of spreadsheets and word processing software.
  • Have ability to problem solve by selecting appropriate alternative from defined options.
  • Is dependable and able to work well within a team.
  • Is interested in learning new things. Open to change.
  • Is optimistic and displays a positive attitude even during periods of adversity.
  • Shows initiative; acts independently with management approval
  • Possesses a high attention to detail#LI-JS1Company InformationVertex is a global biotechnology company that invests in scientific innovation.Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.Please note that Vertex requires COVID-19 vaccination for all employees working in the U.S. as a condition of employment at Vertex, subject to medical, religious or other accommodations or exemptions required by law. We believe this requirement is vital to keeping everyone at Vertex and in our communities safe. This requirement applies to both existing and new employees who may at any time work on-site at a Vertex facility or visit another location on behalf of Vertex (e.g., conferences, customer visits, etc.), including all remote employees. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com.

Keywords: Vertex Pharmaceuticals, Cambridge , Quality Control Analyst - Cell Therapies, Healthcare , Cambridge, Massachusetts