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Quality Control Specialist - Cell Therapy

Semma Therapeutics

Semma Therapeutics

Quality Assurance
Multiple locations
Posted on Tuesday, November 14, 2023

Job Description

General Summary:

The Quality Control Specialist is responsible for supporting with various scientific analyses to evaluate the quality of raw materials, in-process materials, and finished goods and ensure compliance with established standards. This role will also assist with conducting and validating various biological and chemical quality control (QC) assays.

Key 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

  • 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.

  • Improving the laboratory—including managing reagents, materials, improving lab flows, et cetera—with minimal managerial support

  • Performs other duties as assigned

Knowledge and Skills:

  • Ability to performs tasks with strict adherence to cGMP and cGDP principles and high attention to detail

  • Understanding of basic laboratory equipment and practices

  • Proficient in the use of spreadsheets and word processing software

  • Ability to problem solve by selecting appropriate alternative from defined options

  • Demonstrates reliability, positive attitude and team work

  • Shows initiative; acts independently with management approval

  • Role involves rotating weekend, holiday, and evening work

Education and Experience:

  • Bachelors Degree in Sciences or equivalent experience

  • 1+ years of relevant experience

Company Information

Vertex 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.

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