Process Improvement Specialist

Granules • Chantilly, VA

22h • Onsite

About The Position

The Process Improvement Specialist- Pharmaceutical Production Operations & Improvement, is responsible for identifying, developing, and implementing improvement initiatives for manufacturing processes in all stages from product formulation through packaging. The individual will work closely with all departments in the manufacturing and quality environments to drive compliance and right first-time practices. This position requires expertise in all aspects of product manufacturing, ability to work hands on, strong leadership skills, and the ability to collaborate and drive change in a cross-functional environment. The individual performs functions relating to the processing of drug products, ensuring product compliance to established current Good Manufacturing Practices (cGMPs), customer requirements and in conjunction with all Standard Operating Procedures (SOPs). Follows standard procedures to complete tasks, some of which may vary in scope, sequence, complexity, and timing. Applies skills and knowledge to recognize issues and to increase efficiency, throughput, and quality. Responsible for the safe and efficient execution of job duties.

Requirements

• 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.
• 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.

Nice To Haves

• Experience with quality management systems is highly preferred.
• Certified in Six Sigma or a recognized troubleshooting / root cause analysis program.

Responsibilities

• Identify and communicate continuous improvement opportunities.
• May work independently or act as a project lead and facilitate work of others as required.
• 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 as well as 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.

Benefits

• health insurance
• dental insurance
• vision insurance

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level