Quality Control Senior Specialist

Job Description Employer: Vertex Pharmaceuticals Incorporated JOB TITLE: Quality Control Senior Specialist LOCATION: 1 Harbor Street, Boston, Massachusetts, 02210 OPENINGS: 1 DUTIES: Provide a variety of analytical functions that occur in the QC department supporting validation, testing and reporting of in-process, release and stability samples. Ensure activities occur in an efficient and cGMP compliant manner while fostering the Vertex vision and values. Serve as RSL representative in cross-functional, cross-departmental working teams and/or working with outside vendors to meet all laboratory needs. Coordinate and facilitate laboratory activities to meet commitments on-time. Maintain accurate laboratory records and adhere to cGMP/GDP expectations. Participate in planning, executing and/or review of method validations, method transfers and/or equipment qualification/requalification Assist in troubleshooting of analytical methods and/or equipment as required. Authors, reviews, and/or approve data, SOPs, COAs, analytical methods, protocols and reports. Lead compliance related teams working towards the goal of continuous improvement. Perform in-process, release, and stability testing and/or review independently following established methodology, procedures and SOPs. Lead the OOS/OOT investigations/deviations and to identify corrective actions to prevent reoccurrence. REQUIREMENTS: Employer will accept a Bachelor's degree, or foreign equivalent, in health science, pharmaceutical sciences or a related field and 5 years of experience in the job offered or in a Quality Control Senior Specialist-related occupation. Position requires demonstrable experience in the following: Knowledge of US and EU cGMP regulations, guidance and experience with regulatory agency inspections. In-process, release, and stability testing and review independently following established methodology, procedures, and SOPs. Participating in analytical method validation protocol discussions and lead planning and execution and review of method validations and method transfers. Ensuring accurate laboratory records and adhering to cGMP/GDP expectations. Troubleshooting analytical methods and analytical equipment as required. Investigating OOT/OOS results and other deviations. Knowledge of analytical methodologies including HPLC with Empower software. Karl Fisher. Dissolution. FTIR spectrophotometry. UV-VIS Spectrophotometer. Rate of Pay: $94300.00 - $141400.00 CONTACT: Send Resume to futuretalent@vrtx.com. Reference 12140.644. EOE. #LI-DNI Pay Range: $0 - $0 Disclosure Statement: The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law. At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more. 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 Vertexs Policy on Flex @ Vertex Program and may be changed at any time. #LI-Onsite 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 Help Us Achieve Our Mission Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious diseases. The company has approved medicines that treat the underlying causes of multiple chronic, life-shortening genetic diseases cystic fibrosis, sickle cell disease and transfusion-dependent beta thalassemia and continues to advance clinical and research programs in these diseases. Vertex also has a robust clinical pipeline of investigational therapies across a range of modalities in other serious diseases where it has deep insight into causal human biology, including APOL1-mediated kidney disease, acute and neuropathic pain, type 1 diabetes, myotonic dystrophy type 1 and alpha-1 antitrypsin deficiency . Founded in 1989 in Cambridge, Mass., Vertex's global headquarters is now located in Boston's Innovation District and its international headquarters is in London. Additionally, the company has research and development sites and commercial offices in North America, Europe, Australia, Latin America and the Middle East. Vertex is consistently recognized as one of the industry's top places to work, including 14 consecutive years on Science magazine's Top Employers list and one of Fortunes 100 Best Companies to Work For. For company updates and to learn more about Vertex's history of innovation, visit www.vrtx.com or follow us on Facebook, Twitter/X , LinkedIn, YouTube and Instagram. The diversity and authenticity of our people is part of what makes Vertex unique, and we recognize that each employee brings diverse perspectives and strengths. By embracing those strengths and celebrating differences, we are fostering an inclusive culture where each of us can bring our authentic selves to work, inspire innovation together, and change peoples lives. Our vision is clear: to be the place where an authentic, diverse mix of talent want to come, to stay, and do their best work.