Regulatory Deviation & Investigation Writer

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 a motivated and detail-oriented individual to lead technical writing activities supporting quality system records, including deviations, change controls, and CAPAs. This mid-level role offers leadership and responsibility in a dynamic, GMP-compliant manufacturing environment.

The ideal candidate will excel in leading cross-functional collaboration, investigation support, change management, and documentation completion while demonstrating independence. This candidate should have a strong understanding of current Good Manufacturing Practices (cGMP) and FDA regulations and guidelines.

Responsibilities

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

• Author, revise, and review deviation records, including event descriptions, impact and risk assessments, root cause analyses, and corrective/preventive actions.
• Author and manage change controls, including change descriptions, justifications, impact assessments, and implementation plans, in coordination with stakeholders across Manufacturing, Quality, and Engineering.
• Draft, track, and support closure of CAPAs, including action plans, effectiveness checks, and supporting documentation.
• Interview subject matter experts and gather technical information to produce clear, accurate, and inspection-ready documentation.
• Author and revise SOPs, work instructions, protocols, and reports, including updates resulting from CAPA and change control implementation.
• Ensure documentation meets GMP, data integrity, and regulatory standards, and is consistent with established templates and style requirements.
• Manage multiple documentation deliverables concurrently, providing status updates and adjusting priorities to meet due dates.
• Lead cross-functional team meetings, including preparing agendas and documenting meeting notes. Facilitate follow-up meetings regarding previously identified action items.
• Track record and action item status, and escalate overdue or at-risk items to appropriate stakeholders.
• Collaborate with process experts and production personnel to resolve technical questions and documentation gaps.
• Provide recommendations to improve documentation processes and quality system workflows.
• Maintain compliance with company policies, training requirements, cGMP standards, and safety protocols.
• Utilize Word, Excel, Document Management Systems, Quality Management Systems (QMS), and other electronic tools to complete tasks efficiently.
• Perform additional tasks or duties as assigned by management.

Requirements

• Bachelor’s degree in Engineering, Science, English/Communications, or a related field of study.
• 2-5 years’ experience in a GMP manufacturing environment, including drafting standard operating procedures, protocols, and/or reports. Must be familiar with regulatory (FDA) requirements.
• Hands-on experience authoring deviations, change controls, and CAPAs in a GMP quality system (e.g., TrackWise, Veeva, or similar QMS).
• Advanced critical thinking and technical writing skills, with strong attention to detail.
• Strong organizational, communication, and interpersonal skills.

Compensation and Benefits

• Expected pay range per year: $80,000 - $95,000.
• Expected benefits include: Medical, Dental, Vision, PTO, 401K

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.