Process Improvement Specialist

Socket.dev; Chantilly (VA); On-site; USD 95,000 - 130,000; Full time

Job summary

Socket.dev in Chantilly, VA seeks a Process Improvement Specialist- Pharmaceutical Production Operations & Improvement to identify, develop, and implement manufacturing-process improvements across formulation through packaging. You will partner with manufacturing and QA to drive compliance, right-first-time practices, and cross-functional collaboration.

The role requires Lean and Six Sigma expertise, strong communication, and the ability to lead CAPAs, develop metrics, train staff, and perform

Qualifications

• Bachelor degree in a science field or related experience.
• ,
• Excellent communication skills, both written and verbal.
• Strong knowledge of cGMP and FDA regulations.
• Certified Six Sigma or equivalent problem-solving approach.
• Experience with quality management systems is preferred.

Responsibilities

• Identify and communicate continuous improvement opportunities and lead projects.
• Solve complex problems using Lean Six Sigma and other CI tools.
• Develop metrics for process performance and future opportunities.
• Support investigations and CAPA implementation with area leaders.
• Provide coaching and trainings for new and existing processes including GMP training.
• Conduct in-process audits to ensure regulatory compliance and SOP adherence.

Skills

Lean

Six Sigma

Change management

Emotional intelligence

Cross-functional collaboration

Communication

Leadership

Education

Bachelor of Science or related field

Six Sigma certification

Tools

Microsoft Excel

PowerPoint

Word

Outlook

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.