Note: The job is a remote job and is open to candidates in USA. Compunnel Inc. is a global workforce solutions provider committed to fostering an inclusive environment. The Technical Writer – Quality Management Systems (QMS) will develop and revise quality-controlled documentation to support manufacturing operations and ensure compliance with regulatory requirements and internal standards.

Responsibilities

• Author, revise, and maintain controlled documents, including
• Standard Operating Procedures (SOPs)
• Work Instructions Forms and Templates
• Master and Batch Manufacturing Records (MMR/BMR)
• Ensure documents clearly define manufacturing processes, product requirements, and quality controls in alignment with QMS standards and regulatory expectations
• Interpret and translate regulatory requirements (e.g., FDA, ISO, internal quality standards) into structured, compliant documentation
• Ensure documentation supports audit readiness, traceability, and objective evidence requirements
• Maintain consistency with enterprise quality requirements and governance frameworks
• Partner with manufacturing, quality, engineering, and regulatory teams to gather requirements and validate content accuracy
• Facilitate document reviews with subject matter experts (SMEs) to ensure technical and regulatory alignment
• Incorporate feedback and drive timely document completion

Skills

• Bachelor's degree in Technical Writing, Life Sciences, Engineering, or a related field (or equivalent experience)
• 5–8+ years of experience in technical writing within regulated manufacturing environments (e.g., pharmaceutical, tobacco, food, medical device)
• Experience with Quality Management Systems (QMS) and document control processes
• Familiarity with manufacturing documentation (e.g., SOPs, MMR/BMR, specifications)
• Strong understanding of Quality Management Systems (QMS) principles
• Regulatory requirements (e.g., FDA, ISO 9001, GMP concepts)
• Document control and change management processes
• Ability to translate complex technical processes into clear, concise documentation
• Attention to detail and accuracy
• Strong written and verbal communication skills
• Analytical thinking and problem-solving
• Ability to manage multiple priorities and deadlines
• Collaboration and stakeholder engagement
• Experience supporting FDA inspections or regulatory submissions
• Knowledge of data integrity and audit trail expectations
• Certification in technical writing or quality systems (e.g., ASQ, CQIA)

Company Overview

Company H1B Sponsorship