Onsite Metrology Scientist II/III - GMP Lab Specialist

Parexel; Rahway (NJ); In loco; USD 70.000 - 95.000; Tempo pieno

Descrizione del lavoro

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

Competenze

• 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.

Mansioni

• 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.

Conoscenze

GMP laboratory experience

HPLC

GC

UV-Vis spectroscopy

Dissolution systems

SOP writing

Documentation

Independent work

Strong communication

Interpersonal collaboration

Formazione

BS in Chemistry or related field

MS in Chemistry or related field

Strumenti

GMP validation concepts (standalone systems)

Descrizione del lavoro

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