QMS Document Writer-- MEHDC5833689

Position Summary:

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)
• Ensure documents clearly define manufacturing processes, product requirements, and quality controls in alignment with QMS standards and regulatory expectations

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

• 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)

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)

Compunnel Inc. is an Equal Employment Opportunity (EEO) employer committed to fostering an inclusive, diverse, and equitable workplace. All qualified applicants will receive consideration for employment without regard to race, color, religion, creed, sex, sexual orientation, gender identity or expression, national origin, citizenship status, age, disability, protected veteran status, marital status, genetic information, or any other characteristic protected by applicable federal, state, or local law. As a global workforce solutions provider, Compunnel values diversity of thought, background, and experience, and believes an inclusive workforce strengthens innovation and client success.