Job Description
Job Description
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. This position will be located in Worcester, MA.
Position Summary
cGMP Consulting, Inc. is seeking technical writers who would support engineers of all experience levels to provide technical support/ documentation to Engineering and Validation teams with a focus on change management and SOP updates for a variety of on-going projects in the pharmaceutical industry. Knowledge and application of the CFR’s and cGMP’s is preferred.
The ideal candidate for this job is resourceful, independent, organized, and capable of working in a fast-paced environment. Assuring a steady and accurate completion of the workload on time is key to success in this position.
Responsibilities
- Author and revise SOPs, Work Instructions, and controlled documents to ensure clarity, compliance, and alignment with current Good Manufacturing Practices (cGMP), regulatory requirements (e.g., 21 CFR Part 11, EU Annex 11), and internal quality standards.
- Translate change control records into clear procedural updates by collaborating with QA, Validation, Manufacturing, and Engineering to interpret change requests and accurately reflect them in controlled documentation.
- Manage document lifecycle in electronic document management systems (EDMS) such as Veeva Vault, MasterControl, or Documentum, ensuring version control and audit readiness.
- Participate in cross-functional change control meetings, including Change Control Board (CCB) or Quality Review Board (QRB) sessions, to gather context, clarify scope, and align on documentation impacts.
- Conduct impact assessments for procedural changes, evaluating how proposed changes affect existing SOPs, training materials, and regulatory filings, and identifying required updates.
- Ensure traceability and compliance in documentation updates by maintaining clear linkage between change control records, risk assessments (e.g., PFMEA), and revised documents.
- Support training deployment for revised procedures by collaborating with Learning & Development to ensure timely training assignment and completion tracking for impacted personnel.
- Standardize documentation practices across departments, promoting consistency in formatting, terminology, and structure in line with internal style guides and regulatory expectations.
- Prepare documentation for internal audits and regulatory inspections, and respond to document-related queries and CAPAs to support audit readiness.
- Drive continuous improvement in documentation processes by identifying inefficiencies in SOP workflows and proposing enhancements to improve clarity, usability, and compliance.
Requirements
- Bachelors’ degree in Engineering, Science, or a related field of study.
- 0-2 years’ experience in a GMP manufacturing environment.
- Experience in technical writing including drafting standard operating procedures, protocols, and/or reports is preferred.
- Familiar with regulatory (FDA) requirements.
- Business minor or coursework is strongly encouraged.
- Advanced critical thinking and technical writing skills.
- Strong organizational, communication, and interpersonal skills.
Compensation and Benefits
- Expected pay range per year: $65,000-$85,000 USD
- 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.
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