QMS Document Writer

Technical Writer Quality Management Systems (QMS)

The Technical Writer Quality Management Systems (QMS) is responsible for developing and revising Quality controlled documentation that supports manufacturing operations and ensures compliance with applicable regulatory requirements, internal standards, and quality management system expectations. This role translates complex technical, regulatory, and operational requirements into clear, accurate, and inspection ready documents aligned with enterprise document control processes.

Key Responsibilities

• QMS Documentation Development
• Author, revise, and maintain controlled documents, including:
• Standard Operating Procedures (SOPs)
• Work Instructions
• Forms and Templates
• Master and Batch Manufacturing Records (MMR/BMR)
• Regulatory & Compliance Alignment
• 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
• Cross Functional Collaboration
• 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

Qualifications Education

• Bachelor's degree in Technical Writing, Life Sciences, Engineering, or a related field (or equivalent experience)
• Experience
• 58+ 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)

Technical Skills

• 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
• Core Competencies
• 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

Preferred Qualifications (Optional)

• 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)

Employee Benefits

At LanceSoft, full time regular employees who work a minimum of 30 hours a week or more are entitled to the following benefits:

• Four options of medical Insurance
• Dental and Vision Insurance
• 401k Contributions
• Critical Illness Insurance
• Voluntary Permanent Life Insurance
• Accident Insurance
• Other Employee Perks

About LanceSoft

LanceSoft is rated as one of the largest staffing firms in the US by SIA. Our mission is to establish global cross-culture human connections that further the careers of our employees and strengthen the businesses of our clients. We are driven to use the power of our global network to connect businesses with the right people, and people with the right businesses without bias. We provide Global Workforce Solutions with a human touch