MV02-012726 Test Method Transfer - QC Lab

Validation & Engineering Group • Duluth, GA

11d

About The Position

Validation & Engineering Group, Inc. (V&EG) is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services. We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position: Test Method Transfer - QC Lab Support Summary: Lead and coordinate the transfer of analytical test methods from current to the receiving QC laboratory. Review and assess method documentation, validation reports, and transfer protocols for completeness and compliance. Prepare, execute, and document method transfer protocols. Perform hands-on laboratory testing to demonstrate method reproducibility and equivalency between sending and receiving sites. Train receiving laboratory analysts. Evaluate and investigate any discrepancies, deviations, or out-of-specification results during transfer activities. Collaborate with method development, quality assurance, manufacturing, and regulatory teams. Support troubleshooting, method optimization, and lifecycle management after successful transfer.

Requirements

• Bachelor's Degree in Science or Engineering.
• Minimum of 3 years of experience in direct pharmaceutical, medical device or biotechnology industries.
• Must be fully bilingual (English / Spanish) with excellent oral skills.
• Strong knowledge in cGxP and regulatory guidance and compliance.
• Available to work extended hours, possibility of weekends and holidays.

Responsibilities

• Lead and coordinate the transfer of analytical test methods from current to the receiving QC laboratory.
• Review and assess method documentation, validation reports, and transfer protocols for completeness and compliance.
• Prepare, execute, and document method transfer protocols.
• Perform hands-on laboratory testing to demonstrate method reproducibility and equivalency between sending and receiving sites.
• Train receiving laboratory analysts.
• Evaluate and investigate any discrepancies, deviations, or out-of-specification results during transfer activities.
• Collaborate with method development, quality assurance, manufacturing, and regulatory teams.
• Support troubleshooting, method optimization, and lifecycle management after successful transfer.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level