Scientist II or III - Analytical Chemist Metrology Specialist - FSP

Parexel

2d•Onsite

About The Position

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 retirement

Requirements

B.S./M.S. in Chemistry, Biochemistry, Engineering, or a related discipline
Scientist II - B.S. with 1-2 years of relevant experience or M.S. with 0-1 years of relevant experience
Scientist III - B.S. with 3-5 years of relevant experience or M.S. with 1-2 years of relevant experience
Experience working within a regulated (GMP) laboratory
Experience maintaining or operating laboratory equipment including HPLCs, GCs, UVs, dissolution systems, or other specialized computerized systems
Familiarity with standalone computer system validation requirements
Highly organized, and capable of multi-tasking to manage a variety of laboratory equipment or system related schedules, documents, and maintenance tasks
Capable of working independently under moderate supervision
Strong verbal and written communication skills
Strong interpersonal skills. Comfortable interacting with a variety of on-site and off-site collaborators

Nice To Haves

Experience 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 requirements
Familiarity with authoring relevant instrument standard operating procedures (SOPs)

Responsibilities

Prepare, review, and approve instrument/equipment documentation such as master equipment lists, qualification documentation, and calibration documentation
Coordinate service activities across a variety of vendors and service engineers while building and maintaining strong working relationships
Gain 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 packages
Support the purchase, installation, and equipment qualification of new laboratory equipment
Collaborate with metrology staff across multiple testing labs and sites for process improvement, cross-training and cross-site support
Originate and progress Notice of Event (NOE) and Change Management (CM) records
Perform and document investigations and assist in developing/implementing CAPA plans
Represent the laboratory on all aspects of laboratory equipment during audits
Ensure compliance with all regulatory requirements (cGMP) and internal policies and procedures