GMP Operational Quality Specialist (Onsite) at Vertex Pharmaceuticals

Job DescriptionThe Quality Specialist will provide QA support for manufacturing operations analytical laboratory operations and materials management for the internal programs at Vertex Manufacturing Center (VMC) Boston MA.The position will be a part of the QA operation floor support team. This role will review & support activities related to product disposition including batch data batch records deviations in-process data EM data QC release testing and other quality systems documentation. The Quality Specialist supports or executes daily activities related to equipment or instrumentation supporting Facilities Utilities Manufacturing and Labs.The position will support multiple production functions (from Quality operations to Quality Engineering) to achieve site goals while providing Quality oversight and ensuring compliance. Supporting resolution of potential nonconformance events by applying the deviation and CAPA management procedure in conjunction with other procedures as applicable to facilitate decision-making with a cross-functional team as needed. Perform other duties as assigned by the management.This role will require a local presence at the VMC Boston MA site.Key Knowledge/ Skills and Competencies:Strong oral and written communication skills requiredGood Interpersonal skills requiredAttention to detailKnowledge in the following areas:Understanding of global GMP requirements governing oral drug products and knowledge of oral drug product manufacturing practicesOversight of Internal Operations QA Operation and ComplianceAct as a first point of contact in case of QA support for shipping and material transfer.Ensure regular presence in GMP operations areas as needed. Performs Line and area clearance.Responsible for raw material release.Review and approve batch production records and other GMP documentation in support of daily operations.Generate performance metrics trends; including site metrics for investigation/CAPA Equipment and Facility Change Controls etcParticipate in self-led inspections and provide support during internal/external regulatory inspections.Responsible for identifying risks and communicating gaps for GMP process/systemsSupport Lean Transformation and Operational Excellence initiativesAdhering to safety rules and maintaining a safe work environment for both you and others by supporting EHSS corporate and site goalsOversight of Internal Operations Quality EngineeringProvide Quality oversight and review of calibrations PMs eCRs work orders and laboratory operations via instrument qualificationsSupport EM and UM programs and control programsProvide support for facilities and engineering projects including capital projects annual plant shutdowns and various improvement projects as assignedAudit / Inspection SupportParticipate in inspection readiness activities and provide support during regulatory site inspections. Provide post-inspection support to address any regulatory observations.Deployment of QMS and Establishment of Compliance ExpectationsParticipate in process improvement initiatives (as necessary) performing gap analysis and risk communication.Act as a trusted advisor to the site by providing compliance guidance through collaborative review and working with the business owners to gain a better understanding of their needs and facilitate the resolution of quality issues in a timely manner.Individual Development and TrainingResponsible for timely completion of trainings (100% on-time) goal development self-evaluation and IDPMinimum Qualifications:M.S in life sciences (or equivalent degree) orB.S in life sciences (or equivalent degree) and 1-3 years of relevant work experienceAbility to thrive in a high throughput environment.Preferred Qualifications:Affinity with digital innovation data sciences and Quality engineeringExperience with raw material receipt and release inspection & samplingHighly effective verbal and written communication skills strong interpersonal skillsGreat attention to detail and high degree of accuracy in task execution and GMP documentationAbility to providing updates to senior management and identifying potential issuesStrong organizational skills including ability to follow assignments through to completionKnowledge of ASTM E2500 CSV/GAMP and other associated standards is a plusIn 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.Pay Range:$35 - $53Disclosure 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 DesignatedFlex 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-OnsiteCompany 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 persons 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 Required Experience:IC Key Skills Quality Assurance,FDA Regulations,Data Collection,Food Safety Experience,ISO 9001,Mobile Devices,Root cause Analysis,Quality Systems,OSHA,Food Processing,Quality Management,cGMP Employment Type : Full-Time Experience: years Vacancy: 1 Monthly Salary Salary: 35 - 53