Process Improvement Specialist

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

Description

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.

• 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.

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.
• 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. At times it may be necessary to work additional hours in order to get the required tasks accomplished to meet deadlines as we are a multi-shift operation.
• Comply with all Company policies and procedures.
• Comply with all Company safety rules and regulations.

Physical Requirements

Must be able to maneuver at least 50 pounds, climb ladders, wear a respirator and pass associated respirator tests and/or requirements, and be able to wear all required PPE, including safety glasses, ear plugs, and safety shoes

Disclaimer:

The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.