Documentation Specialist

in Pharma
  • Stafford, TX View on Map
  • Salary: $106,000.00 - $123,000.00
Permanent

Job Detail

  • Experience Level Mid Level
  • Degree Type Bachelor of Science (BS)
  • Employment Full Time
  • Working Type Hybrid
  • Job Reference 0000009060
  • Salary Type Annually
  • Industry Pharmaceuticals
  • Selling Points

    Seeking a Hybrid Documentation Specialist to join a highly responsive and supportive client. This role offers the opportunity to contribute to meaningful projects in a dynamic environment.

Job Description

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.
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