Job Description

Technical Writer - GMP SOPs and Work Instructions (Professional Services)

 

Job Description:

We are looking for a Technical Writer with a minimum of 3 years of experience in a GMP-regulated environment. The ideal candidate will be responsible for revising and developing Standard Operating Procedures (SOPs) and work instructions for manufacturing to ensure compliance with industry regulations, including 21 CFR Part 820. This role requires attention to detail, the ability to collaborate with cross-functional teams, and a strong understanding of manufacturing best practices in the medical device industry, or related industries.

 

Key Responsibilities:

SOP and Work Instruction Development: Revise, create, and maintain clear, concise, and compliant SOPs and work instructions in accordance with GMP regulations and company standards. Regulatory Compliance: Ensure all documentation aligns with relevant FDA regulations, specifically 21 CFR Part 820 (Quality System Regulation for medical devices). Document Review and Approval: Collaborate with subject matter experts and quality assurance teams to review and approve documentation, ensuring accuracy and compliance. Process Improvement: Identify opportunities to streamline and improve existing SOPs and work instructions, enhancing efficiency and compliance.

 

Qualifications:

Minimum of 3 years of experience as a Technical Writer in a GMP-regulated environment. Proficiency in revising SOPs and work instructions using MS Word and Excel. Smartsheet experience is a plus. Basic understanding of 21 CFR Part 820 and/or Part 210/211 regulations. Strong attention to detail and excellent writing skills. Ability to work independently and as part of a team. Experience with document management systems and quality management systems (QMS) is a plus. Bachelor’s degree in a relevant field (e.g., English, Communications, Life Sciences, or Engineering) is preferred. English B2+/C1

 

Why Join Us:

Opportunity to work in a dynamic and collaborative environment. Contribute to the development of high-quality, compliant products. Engage in continuous learning and professional growth.