Documentation Specialist

Key Responsibilities:

• Create and maintain documentation: creating, reviewing, and updating documents related to drug development and production processes, including Standard Operating Procedures (SOPs), batch records, protocols, and reports.
• Ensure compliance with regulations: ensures that all documentation is compliant with regulatory requirements and industry standards, including Good Manufacturing Practices (GMPs) and Good Documentation Practices (GDPs).
• Manage document control: manages the document control system, including document creation, revision, distribution, and archiving.
• Collaborate with cross-functional teams: collaborates with cross-functional teams, including Quality Assurance, Quality Control, Manufacturing, and Regulatory Affairs, to ensure that documentation is accurate and up-to-date.
• Provide training on documentation procedures: provides training on documentation procedures to ensure that all employees follow proper documentation practices.
• Ensure accuracy and completeness of documentation: ensures the accuracy and completeness of all documentation by reviewing documents for errors, omissions, and inconsistencies.
• Manage document change control: manages document change control by ensuring that all changes to documents are properly documented, reviewed, and approved.
• Maintain document storage and retrieval systems: maintains document storage and retrieval systems, ensuring that documents are easily accessible and properly organized.
• Perform document audits: performs document audits to ensure that all documentation is complete, accurate, and up-to-date.
• Continuously improve documentation processes: continuously improves documentation processes by identifying areas for improvement and implementing best practices to enhance the efficiency and effectiveness of document management.

Qualifications:

• Bachelor in a Science related field preferred
• Demonstrated organizational skills and ability to manage multiple tasks at once, drive execution and meet critical deadlines.
• Strong communication skills, both verbally and in writing 
• Strong interpersonal skills and ability to train.
• Extremely proficient with MS Office products
• Strong computer skills, including SharePoint and database tools.
• Ability to quickly learn new systems and procedures.