Description

You will manage plant quality performance and technical compliance across production environments.

Responsibilities

• Provide daily production area support to resolve quality issues and drive continuous improvement initiatives.
• Conduct technical reviews of changes to specifications, processes, formulas, packaging, and labeling.
• Oversee the validation program, including risk analysis, validation master plan maintenance, and development of PQ protocols.
• Lead product inspections, line trials, and Technology Transfer Quality Standard activities.
• Utilize quality tools including Change Control, Failure Investigation, Control Charts, and CAPA to drive results.
• Collaborate with Operations, Engineering, Procurement, and Vendors to manage the Management of Change process.

Required Skills

• Bachelor's degree in Chemical Engineering, Mechanical Engineering, Chemistry, or a related science/engineering discipline.
• Minimum of 2-3 years of experience in manufacturing or a dedicated quality role.
• Proficiency with Change Control processes.
• Experience with Failure Investigation methodologies.
• Ability to utilize Control Charts for process monitoring.
• Demonstrated project management skills.
• Experience conducting training on GMP and quality standards.
• Knowledge of validation protocols including IQ/OQ and PQ.

Key Skills

Education

Bachelor's degree