GMP Technical Writer – SOPs, Validation & Audits

Accentuate Staffing; Raleigh (NC); On-site; USD 60,000 - 80,000; Full time

Job summary

Accentuate Staffing in North Carolina seeks an experienced Technical Writer to develop and maintain SOPs and validation protocols in a GMP-regulated environment. You will collaborate with Quality, Manufacturing, and Engineering teams to ensure compliance with regulatory requirements. The ideal candidate has a Bachelor’s degree in a scientific or technical field, 4+ years of relevant experience, and excellent communication skills. Proficiency in Microsoft Office and document management systems is required.

Qualifications

• 4+ years of experience in technical writing within a GMP-regulated environment.
• Experience writing and editing SOPs and validation documentation.
• Strong understanding of cGMP regulations and documentation practices.

Responsibilities

• Develop, edit, and maintain technical documentation including SOPs and validation protocols.
• Collaborate with Quality, Manufacturing, and Engineering teams.
• Support audit readiness efforts and assist during inspections.

Skills

Technical writing

cGMP knowledge

Collaboration

Attention to detail

Communication skills

Education

Bachelor’s degree in a scientific, technical, or related field

Tools

Microsoft Office

Document management systems

Job description

Accentuate Staffing in North Carolina seeks an experienced Technical Writer to develop and maintain SOPs and validation protocols in a GMP-regulated environment. You will collaborate with Quality, Manufacturing, and Engineering teams to ensure compliance with regulatory requirements. The ideal candidate has a Bachelor’s degree in a scientific or technical field, 4+ years of relevant experience, and excellent communication skills. Proficiency in Microsoft Office and document management systems is required.