Quality Control Specialist - Cell Therapy
Job DescriptionGeneral
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 supportPerforms other duties as assignedKey requirements:
Bachelors degree in Sciences1
years of relevant experiencePerforms tasks with strict adherence to cGMP and cGDP principlesHas an understanding of basic laboratory equipment and practicesIs proficient in the use of spreadsheets and word processing softwareHave ability to problem solve by selecting appropriate alternative from defined optionsIs dependable and able to work well within a teamIs optimistic and displays a positive attitude even during periods of adversityShows initiative; acts independently with management approvalPossesses a high attention to detailRole may involve some weekend workCompany 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.
SummaryLocation:
Boston, MA; Cambridge, MAType:
Full time.
Estimated Salary: $20 to $28 per hour based on qualifications.
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 supportPerforms other duties as assignedKey requirements:
Bachelors degree in Sciences1
years of relevant experiencePerforms tasks with strict adherence to cGMP and cGDP principlesHas an understanding of basic laboratory equipment and practicesIs proficient in the use of spreadsheets and word processing softwareHave ability to problem solve by selecting appropriate alternative from defined optionsIs dependable and able to work well within a teamIs optimistic and displays a positive attitude even during periods of adversityShows initiative; acts independently with management approvalPossesses a high attention to detailRole may involve some weekend workCompany 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.
SummaryLocation:
Boston, MA; Cambridge, MAType:
Full time.
Estimated Salary: $20 to $28 per hour based on qualifications.
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