Quality Control Specialist - Cell Therapy
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.
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
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 ApplicationAssistance@vrtx.com.