GMP-Driven QC Analyst: Method Validation & Compliance

Meridian Bioscience International Limited; Memphis (TN); Presencial; USD 55.000 - 75.000; Jornada completa

Descripción de la vacante

The Quality Control Analyst at Meridian Bioscience International Limited performs testing and inspection of raw materials, in-process and finished products, and audits documentation in line with SOPs and regulatory requirements. The role supports method development, validation, and the continued improvement of the Quality System.

The position requires a scientific degree with 2–5 years of relevant experience, strong communication skills, teamwork, and the ability to work in a fast-paced

Formación

• Bachelor's degree in a scientific discipline or equivalent with a minimum of 2 to 5 years relevant experience
• Team-oriented individual with the ability to effectively participate as part of a team
• Proficiently works with all employee levels from executive management to line personnel
• Excellent written and oral communication skills
• Demonstrates ability to train others
• Highly organized and process oriented
• Able to work in a fast-paced environment
• Readily adaptable to changing demands
• Advanced computer literacy
• Proficient with statistical tools (e.g. Minitab) and concepts and their application in a regulated environment
• Knowledge of cGMP, GLP, and ISO preferred
• Travel: 5%

Responsabilidades

• Write and revise SOPs or other controlled documents in accordance with applicable regulations
• Perform data analysis of test results and review data for compliance to SOPs and specifications
• Perform weekly testing of facility purified water systems
• Initiate and complete deviation reports
• Initiate and complete nonconforming product reports
• Initiate and complete out of specification (OOS) investigations and associated reports
• Assist in training and development of new Quality Control Analysts

Conocimientos

Team-oriented

Excellent communication

Train others

Highly organized

Fast-paced environment

Adaptable to changing demands

Advanced computer literacy

Statistical tools (e.g. Minitab)

Educación

Bachelor's degree in a scientific discipline

Herramientas

Minitab

Descripción del empleo

The Quality Control Analyst at Meridian Bioscience International Limited performs testing and inspection of raw materials, in-process and finished products, and audits documentation in line with SOPs and regulatory requirements. The role supports method development, validation, and the continued improvement of the Quality System.

The position requires a scientific degree with 2–5 years of relevant experience, strong communication skills, teamwork, and the ability to work in a fast-paced