Quality Engineer — Drive GMP Quality & Process Insight

WASA Wasatch Product Development; United States; Presencial; USD 70.000 - 110.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Competitive medical, vision, dental

Therapist access

Generous vacation policy

Descripción de la vacante

Wasatch Labs in the United States is seeking a Quality Engineer/Quality Control Specialist to perform laboratory QA/QC tests, calibrate equipment, and prepare samples for shipment. You will analyze data, generate reports, and lead root cause analyses for process deviations.

The role requires 2+ years in a food manufacturing QA environment, with strong knowledge of cGMP, GLP, and ISO standards. On-site work with CAPA and environmental monitoring oversight is expected.

Formación

• Bachelor’s degree in chemical engineering, mechanical engineering, biomedical engineering, bioengineering or related STEM field.
• 2+ years’ laboratory experience in food manufacturing with QA/QC exposure.
• Experience with GMP/GLP, ISO standards and CAPA systems.
• Proven RCA, SPC and data analysis capabilities.
• Ability to manage cleaning and equipment validation protocols.

Responsabilidades

• Perform quality control tests in lab and on-site as needed.
• Test and calibrate lab equipment for tasks and samples.
• Prepare samples prior to shipping to customers.
• Analyze data and prepare reports for management.
• Lead root cause investigations for OOS/OOT with cross-functional teams.

Conocimientos

Root cause analysis

CAPA systems

Statistical process control

cGMP knowledge

ISO 22716 / ISO 13485

GLP guidelines

Effective communication

Cleaning validation

Educación

Bachelor’s degree in chemical engineering or related STEM

Herramientas

pH meter

Analytical balance

Soleris system

Minitab / JMP

Descripción del empleo

Wasatch Labs in the United States is seeking a Quality Engineer/Quality Control Specialist to perform laboratory QA/QC tests, calibrate equipment, and prepare samples for shipment. You will analyze data, generate reports, and lead root cause analyses for process deviations.

The role requires 2+ years in a food manufacturing QA environment, with strong knowledge of cGMP, GLP, and ISO standards. On-site work with CAPA and environmental monitoring oversight is expected.