Job Description
General Summary:
will provide QA oversight of the quality control bioassay and flow cytometry laboratories along with raw material, analytical development, and supply chain groups in support of Vertex Clinical Cell and Gene Therapy Programs. Emphasis on review and approval of quality event management (deviations and analytical investigations (OOS/OOE)), QC and AD owned protocols and reports supporting analytical method lifecycle, justification of material specifications, and stability studies. The role will have additional responsibilities for QA review of documentation supporting change controls, including but not limited to analytical and process development reports and studies.
This position reports to Director Product Quality Lead / GMP Quality - Cell & Gene.
Key Knowledge/ Skills and Competencies
Direct experience executing, troubleshooting, or investigating flow cytometry, ELISA, bioassay, and automated cell counting QC methods.
Experience supporting GMP testing in a controlled environment (QC and AD), deviation review and oversight, corrective action / preventative action (CAPA), change management, and coordinating risk assessments .
Providing quality oversight and support to Vertex Cell and Gene Therapy quality control, stability, supply chain, and raw material laboratories
REQUIRED EDUCATION AND EXPERIENCE:
On-Site Role
On-Site designated role, you will work five days per week on-site with ad hoc flexibility.
#LI-Onsite #ND-2
Flex Designation:
Hybrid-Eligible Or On-Site Eligible
Flex Eligibility Status:
In this Hybrid-Eligible role, you can choose to be designated as:
1. Hybrid: work remotely up to two days per week; or select
2. On-Site: work five days per week on-site with ad hoc flexibility.
Note: The Flex status for this position is subject to Vertex’s Policy on Flex @ Vertex Program and may be changed at any time.
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 ApplicationAssistance@vrtx.com