Job Description

Accentuate Staffing is partnering with a leading pharmaceutical manufacturing organization to identify a Technical Writer to support documentation and compliance efforts within a GMP-regulated environment. This individual will play a key role in developing, editing, and maintaining critical documentation to support quality, validation, and manufacturing operations. The ideal candidate will have experience working cross-functionally in a fast-paced, highly regulated setting and will be comfortable translating technical processes into clear, compliant documentation.

Responsibilities:

1. Develop, edit, and maintain technical documentation including SOPs, work instructions, validation protocols, and reports
2. Collaborate with Quality, Manufacturing, and Engineering teams to ensure documentation aligns with GMP standards and operational processes
3. Support documentation related to validation activities, including process, equipment, and cleaning validation
4. Ensure all documentation meets regulatory requirements (FDA, cGMP) and internal quality standards
5. Assist with document control processes, including versioning, change controls, and approvals
6. Review existing documentation for accuracy, clarity, and compliance; recommend and implement improvements
7. Support audit readiness efforts and assist during internal and external inspections as needed
8. Translate complex technical information into clear, concise, and user-friendly documentation for various audiences

Requirements:

1. Bachelor’s degree in a scientific, technical, or related field (or equivalent experience)
2. 4+ years of experience in technical writing within a GMP-regulated environment (pharma, biotech, or similar)
3. Experience writing and editing SOPs, validation documentation, and/or quality-related documents
4. Strong understanding of cGMP regulations and documentation practices
5. Excellent written and verbal communication skills with strong attention to detail
6. Ability to work cross-functionally and manage multiple priorities in a fast-paced environment
7. Proficiency in Microsoft Office and document management systems

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