Scientist II or III - Metrology Specialist - FSP

About the role

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.

Responsibilities

• Prepare, review, and approve instrument/equipment documentation such as master equipment lists, qualification documentation, and calibration documentation
• Cookordinate 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
• 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

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)

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.