Documentation Specialist SARDC

Responsibilities

• Develop, produce, and maintain complex technical and user documentation.
• Plan and execute writing projects involving detailed and technical content.
• Present complex information clearly and effectively, ensuring timely progress reporting against schedule milestones.
• Utilize advanced word processing tools and software applications.
• Determine project requirements and perform complex writing, copy editing, technical editing, and documentation design activities.
• Create document structures and graphics at the project level.
• Write consistent, clear, and accurate documentation that simplifies complex information.

• Manage control of Quality Management System (QMS) and GMP-critical documentation.
• Coordinate and track document reviews and approvals efficiently.
• Maintain accurate records of document status, change controls, reviews, and approvals.
• Ensure documents comply with established templates, formatting, naming, and numbering standards.
• Verify document cross-references for accuracy and traceability.
• Maintain electronic document libraries and QMS document inventory, including document identification, status, and effective dates.
• Manage and control quality records as required.
• Distribute and retrieve controlled documentation at points of use.
• Process requests for copies of controlled documents and quality records.
• Sort, file, and maintain controlled documents and quality records.
• Coordinate off-site document storage activities when necessary.

• Bachelor’s degree with 3–5 years of experience, or equivalent experience.
• Bachelor’s degree or high school diploma with relevant GMP or document control experience.
• Experience in document control within a GMP-controlled environment.
• Proficiency in Microsoft Office (Word, Excel, PowerPoint) and ability to learn new systems.
• Strong writing, editing, and documentation design skills.
• Excellent organizational skills and attention to detail.
• Ability to communicate effectively in English (written and verbal).
• Ability to work independently with minimal supervision.
• Capable of working in a fast-paced environment and meeting multiple deadlines.
• Experience collaborating with cross-functional teams and departments.
• Ability to perform physical tasks, including lifting up to 30 lbs and handling document storage activities.
• Self-motivated, adaptable, and results-oriented with strong interpersonal skills.