Process Improvement Specialist
Akorn 2

The Process Improvement Specialist 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 the 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.

• 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 Operational Excellence or Production relating to process improvement.
• Ability to work effectively as a cross-functional team.
• Proficient in Microsoft 365 and Smartsheet.
• Strong communication skills and presentation skills.
• Ability to abide by quality standards.

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 (minimum of a Green belt, Black belt preferred) 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 sterile 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.

Company Overview
Akorn, Inc. is a niche pharmaceutical company that develops, manufactures and markets generic and branded prescription pharmaceuticals as well as animal and consumer health products. We specialize in difficult-to-manufacture sterile and non-sterile dosage forms including: ophthalmics, injectables, oral liquids, topicals, inhalants, and nasal sprays. Akorn markets its products to retail pharmacies, ophthalmologists, optometrists, physicians, veterinarians, hospitals, clinics, wholesalers, distributors, group purchasing organizations, and government agencies.

EEO Statement
Akorn, Inc. is an Equal Opportunity Employer and takes pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.

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