Pharma Process Improvement Lead | Lean Six Sigma

Granules Pharmaceuticals; Chantilly (VA); On-site; USD 90,000 - 130,000; Full time

Job summary

Granules Pharmaceuticals in Chantilly, VA seeks a Process Improvement Specialist to identify and implement manufacturing process improvements from formulation through packaging. You will drive cGMP compliance, lead cross-functional teams, and apply Lean/Six Sigma methods to raise throughput and quality.

A BS in Science or related field, Six Sigma certification, excellent communication, and knowledge of FDA regulations are required.

Qualifications

• Bachelor degree in science or related field.
• Excellent oral and written communication skills.
• Experience with quality management systems preferred.
• Six Sigma certification.
• Knowledge of FDA cGMP regulations for drug manufacturing.
• Willingness to work 40-hour week and overtime as needed.

Responsibilities

• Identify and communicate continuous improvement opportunities.
• Lead Lean/Six Sigma projects to improve throughput and quality.
• Develop metrics and indicators for process measurement.
• Create and revise Master Batch Records, SOPs, and forms.
• Collaborate on CAPA development and action plans with area leaders.
• Coach and train others in process improvements and GMP training.
• Perform in-process audits to ensure regulatory compliance.

Skills

Lean Six Sigma

Cross-functional collaboration

Communication

Change management

Emotional intelligence

Education

Bachelor's degree in Science or related field

Tools

Microsoft Excel

Microsoft Word

PowerPoint

Microsoft Outlook

Quality Management Systems (QMS)

Job description

Granules Pharmaceuticals in Chantilly, VA seeks a Process Improvement Specialist to identify and implement manufacturing process improvements from formulation through packaging. You will drive cGMP compliance, lead cross-functional teams, and apply Lean/Six Sigma methods to raise throughput and quality.

A BS in Science or related field, Six Sigma certification, excellent communication, and knowledge of FDA regulations are required.