Quality Sr Specialist - Packaging/ Labeling

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Job description

Job DescriptionThe Sr. Specialist works with a high degree of independence, while providing oversight of the development, implementation and maintenance of relevant quality initiatives in support of their function. The Sr. Specialist completes work in a resourceful, self-sufficient manner and is able to design alternative approaches to achieve desired outcomes. They are adept at troubleshooting problems, coordinating and executing activities on multiple complex projects ensuring alignment with corporate goals and compliance with all regulatory requirements. This role would require on site presence (3 days in the office/ 2 days remote).Key Responsibilities:The responsibilities of this position may include, but are not limited to, the following:Perform disposition activities for Finished Goods in support of Commercial Product, including:Master and Executed Batch Record review and resolution of comments/issuesEvaluations of Investigations/ OOS/ Change Controls to support Disposition StatusCertificate of Analysis approvalStatus change in OracleArchiving of batch documents in electronic document system, QDoCCSAssist with Material Review Board activities, when necessaryLead quality oversight of artwork/label review, approval, & implementationProvides quality guidance for root-cause analysis and product impact assessment for investigations as a result of deviations, OOS, and OOT investigations ensuring appropriate CAPA actions are identifiedDevelops relationships with strategic external partners in support of Vertex's expanding commercial portfolio and assist with ongoing relationships.QP Relationship and ReleaseFacilitate QP Release of finished goodsAssist with QP Declaration requestsIncorporate QP expectations into quality systemsProvide compliance guidance to Commercial project teamsCollaborative reviewer of internal proceduresInvestigation guidanceEstablishment of Quality Processes/Process Ownership - Packaging /Labeling and QP Release of Finished GoodsServe as review/approver or owner of deviationsMonitors and trends events and identifies/proposes corrective actionsMay serve as CAPA ownerIdentifies risks and communicates gaps to managementAssists with the generation of process related metrics/monitors for efficiencyCommercial Change ControlServe as QA assessor/approver: resolve gaps, approve change plans, classifications, strategy for GMP release and disposition strategy.Key requirements:Degree and relevant work experience in a scientific or allied health fieldStrong experience in batch review/ disposition process with a good understanding of packaging/ labeling operationsAttention to detailGMP understanding and knowledge of oral drug product manufacturing practicesAbility to manage change and thrive in a high throughput environment working independentlyUnderstanding of Project Management / Continuous ImprovementCritical Thinking / Problem SolvingAbility to evaluate quality matters and make decisions utilizing risk based approach.Company 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. 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 .