About Us

At cGMP Consulting, we specialize in providing expert validation, qualification, and compliance services to the life sciences industry. Our team works with clients to ensure their facilities, equipment, and processes meet regulatory standards, enabling the safe and efficient production of pharmaceuticals.
cGMP Consulting is based in Lake Forest, IL. Our main client locations are Melrose Park, IL, North Chicago, IL, Waukegan, IL and Pleasant Prairie, WI. 

Position Summary

cGMP Consulting is seeking an experienced Contract Manufacturing Organization Quality Assurance Engineer with knowledge in packaging and labeling of final drug product. This individual will support overseeing quality systems, managing deviations, and ensuring regulatory requirements are met. This senior level role offers leadership and responsibility in a dynamic, GMP-compliant manufacturing environment. 

Responsibilities 

The essential functions include, but are not limited to the following: 

• Develop and maintain quality systems, including change controls, deviations, and investigations.
• Conduct and support audits to assess their compliance with quality standards, regulations, and client-specific requirements.
• Investigate and resolve deviations, OOS results, and other quality related issues at the CMO.
• Review and approve change requests related to the manufacturing processes, materials, and other aspects of the CMO's operation.
• Review and approve batch records, ensure products meet quality standards before release.
• Maintain clear communication with internal teams and stakeholders.
• Ensure that the CMO's operations comply with relevant regulations and guidelines.
• Track and report on key quality metrics to monitory CMO performance and identify areas for improvement.
• Perform additional tasks or duties as assigned by management. 

Requirements 

• Bachelors’ degree in Engineering, Science, or a related field of study. 
• 10+ years’ experience in a GMP manufacturing environment, Production, Quality Assurance.
• Knowledge of FDA regulations.
• Advanced critical thinking and technical writing skills. 
• Strong organizational, communication, and interpersonal skills. 

Compensation and Benefits 

• Expected pay per hour: $125 USD 

Disclaimer 

The duties and responsibilities described are not a comprehensive list and additional tasks may be assigned to the employee from time to time; or the scope of the job may change as necessitated by business demands. All duties and responsibilities are subject to possible modification to reasonably accommodate individuals with disabilities. The requirements listed are the minimum levels of knowledge, skills, or abilities necessary to perform this job successfully. The company is an Equal Opportunity Employer, drug-free workplace, and complies with ADA regulations as applicable.