New

Quality Control Specialist

Vertex Pharmaceuticals Incorporated
United States, Massachusetts, Boston
50 Northern Avenue (Show on map)
Oct 09, 2024
Job Description General Summary: This role provides data review support for GXP Operations Support department supporting Environmental and utility monitoring program, validation, in-process, release and stability samples, and manufacturing batch records Key Duties and Responsibilities: Perform cGMP analytical and microbiological data review for various techniques such as HPLC, GC, KF, TOC, Bioburden, endotoxin, IR and dissolution to ensure adherence to established methodology, procedures and SOPs Review laboratory instrument qualification and requalification packages executed by vendors May author, compile, summarize and review analytical data in various physical and electronic report formats such as analytical reports and certificate of analysis Review laboratory equipment logbooks Ensure all laboratory records are accurate and adhere to cGMP/GDP expectation May conduct training of personnel for specific functions Authors, revises, and processes of workflows for batch records, SOPs, Wis, training related documentation and other documents for VMC operations Investigations, CAPAs, and other QMS record management as needed Perform batch record review Support QC departments in the build and/or revision, review and approval of master data, including but not limited to products, specifications, and methods in LIMS, per global and local LIMS procedures. Coordination and collaboration with internal VMC groups and other Vertex groups who interact with the VMC Support QC departmentsin the build and/or revision, review and approval of master data, including but not limited to products, specifications, and methods in LIMS, per global and local LIMS procedures. Knowledge and Skills: Strong knowledge of analytical methodologies such as chromatography, dissolution, and Karl Fisher and applying/interpretation of GMP requirements. The ability to work in a fast-paced environment, manage priorities and maintain timelines for multiple projects is essential. Strong attention to detail Effective communication skills, both verbal and written. Education and Experience: Bachelor's degree in science or related discipline with 1-4 years of experience in GMP pharmaceutical/biopharmaceutical industry or equivalent combination of education and experience Flex Designation: On-Site Designated Flex Eligibility Status: In this On-Site designated role, you will 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