Pharma Operations Excellence Specialist

Granules Pharmaceuticals, Inc.; Chantilly (VA); On-site; USD 37,000 - 50,000; Full time

Job summary

Granules Pharmaceuticals, Inc. is seeking a Process Improvement Specialist- Pharmaceutical Production Operations & Improvement to identify, develop, and implement manufacturing process enhancements from formulation to packaging.

You will collaborate with manufacturing and quality teams to improve compliance, efficiency, throughput, and first-time quality. The role requires hands-on expertise in drug manufacturing processes, strong leadership, and the ability to drive cross-functional change

Qualifications

• Bachelor Degree of Science / related field or equivalent combination of education and work experience in related field.
• Excellent oral and written communication skills.
• Strong emotional intelligence and change management aptitudes.
• Proficient at Microsoft Outlook, Excel, Word, and PowerPoint.
• Experience with quality management systems is highly preferred.
• Certified in Six Sigma or a recognized troubleshooting / root cause analysis program.
• Have a thorough knowledge or ability to learn applicable FDA/ Current Good Manufacturing Practices and Code of Federal Regulation as it pertains to drug manufacturing.
• Must possess a steadfast quality mindset and commitment to a Good Manufacturing Practice culture.
• Ability to meet attendance standards. All full-time employees are required to work a 40-hour week on the assigned shift.
• Comply with all Company policies and procedures.
• Comply with all Company safety rules and regulations.

Responsibilities

• Identify and communicate continuous improvement opportunities.
• Solve complex problems by utilizing Lean, Six Sigma, or other continuous improvement tools and methodologies.
• Develop metrics that provide data for process measurement, identifying indicators for future improvement opportunities.
• Follow up and support investigations assigned to site Operations.
• Create, review, and/or revise Master Batch Records, Standard Operating Procedures, forms, and other supporting documentation.
• Jointly responsible for CAPA development with area leaders and implementation of action plans related to process improvement.
• Promote teamwork and open discussion of issues and providing coaching and guidance to others.
• Develop and perform trainings for new and existing processes including GMP training.
• Perform in-process audits to ensure compliance of regulations and written instructions.
• Special assignments from Manager of Production relating to process improvement.
• Ability to work effectively as a cross-functional team.
• Ability to abide by quality standards.

Skills

Communication

Change management

Cross-functional collaboration

Problem solving

Quality mindset

Education

Bachelor Degree of Science / related field

Tools

Microsoft Office

Job description

Granules Pharmaceuticals, Inc. is seeking a Process Improvement Specialist- Pharmaceutical Production Operations & Improvement to identify, develop, and implement manufacturing process enhancements from formulation to packaging.

You will collaborate with manufacturing and quality teams to improve compliance, efficiency, throughput, and first-time quality. The role requires hands-on expertise in drug manufacturing processes, strong leadership, and the ability to drive cross-functional change