Scientist II or III - Metrology Specialist - FSP

Parexel; Rahway (NJ); On-site; USD 70,000 - 95,000; Full time

Job summary

Parexel is seeking a Scientist II or III - Metrology Specialist for a full-time, long-term assignment onsite at a client site in Rahway, NJ. The role requires GMP lab experience and hands-on work with HPLC, GC, UV-Vis, and dissolution systems, as well as SOP development and calibration documentation.

Responsibilities include managing instrument records, coordinating vendor service, validating new equipment, and supporting CAPA initiatives while ensuring cGMP compliance across multiple labs and

Qualifications

• Experience in GMP-regulated laboratory environments.
• Experience maintaining, operating and troubleshooting HPLC/GC/UV-Vis and dissolution systems.
• Familiarity with GMP validation of standalone computer systems.
• Ability to organize tasks and manage multiple instruments and schedules.
• Ability to work independently under moderate supervision and communicate clearly.

Responsibilities

• Prepare, review, and approve instrument documentation and calibration records.
• Coordinate service activities with vendors and engineers while maintaining relationships.
• Gain knowledge of lab equipment to troubleshoot or perform maintenance.
• Participate in computer system validation activities for new or upgraded equipment or software.
• Support purchase, installation, and qualification of new lab equipment.
• Collaborate with metrology staff across sites for cross-training and improvements.
• Originate and progress NOE and CM records.
• Conduct investigations and assist in CAPA development and implementation.
• Represent the lab during audits and ensure regulatory compliance.

Skills

GMP laboratory experience

HPLC

GC

UV-Vis spectroscopy

Dissolution systems

SOP writing

Documentation

Independent work

Strong communication

Interpersonal collaboration

Education

BS in Chemistry or related field

MS in Chemistry or related field

Tools

GMP validation concepts (standalone systems)

Job description

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 any sponsorship.

Qualifications –

• Scientist 2 - B.S. with 1-2 years of relevant experience or M.S. with 0-1 years 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
• Experience maintaining, 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 system GMP 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
• 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

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!