Regulatory Deviation & Investigation Writer

cGMP Consulting•Joliet, IL

9d•$80,000 - $95,000

About The Position

cGMP Consulting is seeking a motivated, detail-oriented mid-level Regulatory Deviation & Investigation Writer to lead technical writing activities for quality system records, including deviations, change controls, and CAPAs. The role supports a dynamic, GMP-compliant manufacturing environment and requires independence, cross-functional collaboration, investigation support, change management, and thorough documentation. The candidate should understand current Good Manufacturing Practices (cGMP) and FDA regulations and guidelines. cGMP Consulting provides validation, qualification, and compliance services to the life sciences industry. It is based in Lake Forest, Illinois, with main client locations in Melrose Park, North Chicago, Waukegan, Illinois, and Pleasant Prairie, Wisconsin.

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.
Familiarity with FDA regulatory requirements.
Hands-on experience authoring deviations, change controls, and CAPAs in a GMP quality system, such as TrackWise, Veeva, or a similar QMS.
Advanced critical-thinking and technical-writing skills, with strong attention to detail.
Strong organizational, communication, and interpersonal skills.

Responsibilities

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, coordinating with Manufacturing, Quality, and Engineering stakeholders.
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, 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 follows established templates and style requirements.
Manage concurrent documentation deliverables, provide status updates, and adjust priorities to meet due dates.
Lead cross-functional team meetings, prepare agendas, document meeting notes, and facilitate follow-up meetings about 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.
Recommend improvements to documentation processes and quality system workflows.
Maintain compliance with company policies, training requirements, cGMP standards, and safety protocols.
Use Word, Excel, Document Management Systems, Quality Management Systems (QMS), and other electronic tools to complete tasks.
Perform additional tasks or duties as assigned by management.