[Remote] QMS Document Writer-- MEHDC5833689
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