Create and maintain documentation: The Documentation Specialist is responsible for 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: The Documentation Specialist 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: The Documentation Specialist manages the document control system, including document creation, revision, distribution, and archiving.
Collaborate with cross-functional teams: The Documentation Specialist 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: The Documentation Specialist provides training on documentation procedures to ensure that all employees follow proper documentation practices.
Ensure accuracy and completeness of documentation: The Documentation Specialist ensures the accuracy and completeness of all documentation by reviewing documents for errors, omissions, and inconsistencies.
Manage document change control: The Documentation Specialist manages document change control by ensuring that all changes to documents are properly documented, reviewed, and approved.
Maintain document storage and retrieval systems: The Documentation Specialist maintains document storage and retrieval systems, ensuring that documents are easily accessible and properly organized.
Perform document audits: The Documentation Specialist performs document audits to ensure that all documentation is complete, accurate, and up-to-date.
Continuously improve documentation processes: The Documentation Specialist 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.
Seniority level
Director
Employment type
Full-time
Job function
Administrative
Industries
Staffing and Recruiting
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