Quality Control Analyst

Company: vertex pharmaceuticals
Location: Cranston
Posted on: June 22, 2022

Job Description:

Job Description General Summary: In June 2019, Vertex announced the establishment of a new research site in the Boston area where research, development, and clinical manufacturing for cell and genetic therapies will be primarily based. Cell and genetic therapies represent two rapidly emerging therapeutic modalities with the potential to treat-and even cure-several of the diseases Vertex is focused on, including sickle cell disease, Duchenne muscular dystrophy and type 1 diabetes. Further investment in a research site specifically designed to advance these programs will be key to Vertex's continued and sustained leadership in these exciting approaches. At Vertex Cell and Genetic Therapies (VCGT) our research teams will bring together the best biology, technologies and enhanced manufacturing capabilities to ensure we bring these cutting-edge transformative therapies to patients as quickly as possible. The Quality Control (Device) Analyst is responsible for supporting testing needs for the T1D Device. They will provide support 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 quality control (QC) assays. Key Duties and Responsibilities: Follow SOPs, qualify assays, adhere to GDP practices, conduct statistical analysis of test results Execute materials characterization of device materials including functional, mechanical, and chemical testing Evaluate properties of new and existing raw materials that are currently or will be used in development. Evaluations would be based on collection of data from common polymer analytical equipment including FTIR, DSC, and others Execute release testing per RMS requirements for raw materials to be used in GMP manufacture Collaborate with the QC, PD and manufacturing teams at Providence to execute testing in a timely manner, train personnel on new techniques Maintain regular dialog with AD personnel, assist in transferring developed assays from AD to QC Maintain relationships with external suppliers and scientific partners Knowledge and Skills: Experience performing QC tests in a GMP environment Prior experience using FTIR, DSC, Viscometer or other lab equipment Experience executing USP chemical identity tests for raw materials Experience setting up stability programs for raw materials Experience with qualification and validation of equipment and test method Critical thinking and independence, ability to troubleshoot, solve difficult problems, and develop process/assay improvements Proven ability to multitask and prioritize workload Education and Experience: Bachelor's degree Typically 1+ year experience in analytical testing for a GMP therapeutic program or the equivalent combination of education and 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. 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, Cranston , Quality Control Analyst, Professions , Cranston, Rhode Island