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Scientist II or III - Metrology Specialist - FSP

PAREXEL

When our values align, there's no limit to what we can achieve.At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.We are looking tofill aScientistIIorIII- Metrology Specialistposition working as a full-time employee of Parexel FSP on long-term assignment onsite at one of our clientslocatedinRahway,NJ. This position offers full benefits, sick time, 401K, paid holidays, and paid time off. This position does not offer any sponsorship.Metrologyspecialistisresponsible for the oversight of regulated and non-regulated laboratory equipment. This role will oversee the lifecycle of the lab instrumentation covering acquisition and installation, performance or coordination of routine maintenance, computer system validation, and regulated systems retirementQualifications–B.S./M.S.in Chemistry, Biochemistry, Engineering, or a related disciplineScientist2- B.S. with1-2years of relevant experienceor M.S. with0-1years of relevant experienceScientist 3- B.S. with 3-5 years of relevant experience or M.S. with 1-2 years of relevant experienceRequired Skills and ExperienceExperience working within a regulated (GMP) laboratoryExperiencemaintaining, operating, and troubleshooting laboratory equipment including High-Performance Liquid Chromatography (HPLC), Gas Chromatography (GC), Ultraviolet-Visible spectroscopy (UV-Vis), dissolution systems, and other specialized computerized systems.Familiarity with standalone computer systemGMPvalidation requirementsHighly organized, and capable of multi-tasking to manage a variety of laboratory equipment or system related schedules, documents, and maintenance tasksCapable of working independently under moderate supervision Strong verbal and written communication skillsStrong interpersonal skills. Comfortable interacting with a variety of on-site and off-site collaboratorsFamiliarity with authoring relevant instrument standard operating procedures (SOPs)ResponsibilitiesPrepare, review, and approve instrument/equipment documentation such as master equipment lists, qualification documentation, and calibration documentationCoordinate service activities across a variety of vendors and service engineers while building andmaintainingstrong working relationshipsGain a working knowledge of laboratory equipment tofacilitatewith troubleshooting and/or perform maintenance or calibration activities Participate in computer system validation activities associated with new or upgraded equipment or software packagesSupport the purchase, installation, and equipment qualification of new laboratory equipmentCollaborate with metrology staff across multiple testing labs and sites for process improvement, cross-training and cross-site supportOriginate and progress Notice of Event (NOE) and Change Management (CM) recordsPerform and document investigations andassistin developing/implementing CAPA plansRepresent the laboratory on all aspects of laboratory equipment during auditsEnsure compliance with all regulatory requirements (cGMP) and internal policies and proceduresAbout ParexelParexel FSP includes the CMC Operations group. We provide pharmaceutical and biopharmaceutical companies with qualified and talented technical professionals to support the development and delivery of new therapies.For results-driven and caring individuals who want to make a meaningful difference in the world, Parexel is trusted by life sciences companies to meet their long-term staffing needs for scientists and engineers and related professionals in discovery and development of novel therapies, keeping patients at the center of everything we do, and where an inclusive community helps you be your best, transforming any career into a life-changing achievement.Come join us!#LI-DK1EEO DisclaimerParexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.SummaryLocation: United States - New Jersey - Client OnsiteType: Full time

Vacancy posted 23 hours ago
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