Scientist II or III – Analytical Chemist Metrology Specialist

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 to fill a Scientist II or III - Metrology Specialist position working as a full-time employee of Parexel FSP on long-term assignment onsite at one of our clients located in Rahway, NJ. This position offers full benefits, sick time, 401K, paid holidays, and paid time off. This position does not offer sponsorship. Metrology specialist is responsible 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 disciplineScientist II - B. S. with 1-2 years of relevant experience or M. S. with 0-1 years of relevant experienceScientist III - B. S. with 3-5 years of relevant experience or M. S. with 1-2 years of relevant experienceResponsibilitiesPrepare, 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 and maintaining strong working relationshipsGain a working knowledge of laboratory equipment to facilitate with 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 and assist in developing/implementing CAPA plansRepresent the laboratory on all aspects of laboratory equipment during auditsEnsure compliance with all regulatory requirements (cGMP) and internal policies and proceduresRequired Skills and ExperienceExperience working within a regulated (GMP) laboratoryExperience maintaining or operating laboratory equipment including HPLCs, GCs, UVs, dissolution systems, or other specialized computerized systemsFamiliarity with standalone computer system validation 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 collaboratorsDesired Skills and ExperienceExperience with maintenance of analytical instrumentation such as HPLC, UPLC, GC, UV, IR, Karl Fischer, and dissolution with ability to troubleshoot them. Experience with computerized standalone systems GMP validation requirementsFamiliarity with authoring relevant instrument standard operating procedures (SOPs)About 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! EEO 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. Originally posted on Himalayas Apply To this Job