Scientist II or III - Analytical Chemist Metrology Support - FSP

Parexel International; New Jersey; On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

Full benefits

Sick time

401K

Paid holidays

Paid time off

Job summary

Parexel is seeking a Scientist II/III – Analytical Chemist Metrology Support for a full-time, on-site role in Rahway, NJ. The candidate will oversee regulated and non-regulated laboratory equipment lifecycle, including validation, installation, maintenance, and retirement of instruments.

Required are a B.S./M.S. in Chemistry, Biochemistry, Engineering or related discipline and GMP laboratory experience, plus strong skills with HPLC/GC/UV-Vis and SOPs. Competitive benefits offered.

Qualifications

• B.S./M.S. in Chemistry, Biochemistry, Engineering or related discipline.
• Experience in a regulated GMP laboratory.
• Experience maintaining/operating/troubleshooting HPLC, GC, UV-Vis, dissolution systems.

Responsibilities

• Prepare, review, and approve instrument/equipment documentation (master equipment lists, qualification documentation, calibration records).
• Coordinate service activities with vendors and engineers, building strong working relationships.
• Gain knowledge of laboratory equipment to troubleshoot or perform maintenance/calibration.
• Participate in computer system validation activities for new or upgraded equipment/software.
• Assist in purchase, installation and qualification of new laboratory equipment.
• Collaborate with metrology staff across labs/sites for process improvements and cross-training.
• Progress notices and change management records.
• Perform investigations and assist in developing CAPA plans.
• Represent the lab during audits and ensure cGMP compliance.

Skills

GMP

HPLC

GC

UV-Vis

Dissolution systems

SOPs

Documentation

Communication

Independent work

Team collaboration

Education

B.S. in Chemistry

M.S. in Chemistry

B.S. in Biochemistry

B.S. in Engineering

Job description

We are looking tofill aScientistIIorIII- Analytical Chemist Metrology Supportposition 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.

Metrologysupportisresponsible 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

Qualifications–B.S./M.S.in Chemistry, Biochemistry, Engineering, or a related discipline

• Scientist2- B.S. with1-2years of relevant experienceor M.S. with0-1years of relevant experience

• Scientist 3- B.S. with 3-5 years of relevant experience or M.S. with 1-2 years of relevant experience

Required Skills and Experience

• Experience working within a regulated (GMP) laboratory

• Experiencemaintaining, 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 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

• 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 andmaintainingstrong working relationships

• Gain 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 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 andassistin 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

About Parexel

Parexel 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!

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EEO Disclaimer Parexel 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.