GMP Technical Writer – Pharma Documentation Expert

Cedent; Springfield (NJ); On-site; USD 70,000 - 90,000; Full time

Job summary

A pharmaceutical company in New Jersey is seeking a detail-oriented GMP Pharmaceutical Technical Writer. This role involves creating and maintaining controlled documentation to meet GMP regulations. The ideal candidate will collaborate with internal teams to ensure the accuracy and clarity of technical documents crucial for manufacturing. Qualifications include a Bachelor's degree in a relevant field and at least 2 years of experience in technical writing within a GMP-regulated environment. Proficiency in document management systems is required.

Qualifications

• 2+ years of technical writing experience in GMP-regulated environments.
• Ability to create SOPs, validation protocols, and technical reports.
• Solid understanding of GMP regulations (FDA, EMA, ISO, ICH).

Responsibilities

• Author and maintain documents like SOPs and validation protocols.
• Ensure compliance with regulatory and GMP requirements.
• Coordinate with internal and external stakeholders to align on deliverables.

Skills

Attention to detail

Technical documentation

Regulatory compliance

Project management

Analytical skills

Education

Bachelor's degree in Life Sciences, Chemistry, Pharmaceutical Sciences, Engineering, or related field

Tools

Document management systems

Microsoft Office (Word, Excel, PowerPoint)

Job description

A pharmaceutical company in New Jersey is seeking a detail-oriented GMP Pharmaceutical Technical Writer. This role involves creating and maintaining controlled documentation to meet GMP regulations. The ideal candidate will collaborate with internal teams to ensure the accuracy and clarity of technical documents crucial for manufacturing. Qualifications include a Bachelor's degree in a relevant field and at least 2 years of experience in technical writing within a GMP-regulated environment. Proficiency in document management systems is required.