Documentation Specialist

Description

This position is a key member of the Manufacturing Systems Engineering team. In this role, you will execute various tasks surrounding the management of various types of documentation as well as provide administrative support for the Manufacturing Systems Engineering team.

This can be a remote or in office position in our Coral Gables, FL home office.

Requirements

• Support and manage the authoring, development, and finalization of documents (such as but not limited to SOPs, Policies, WIs, validation documents, etc.), often focusing on software systems that require an intermediate level of technical acumen
• Effectively track and monitor documentation through the document life cycle and ensure continued compliance, using MS Office tools as well as Veeva Quality Docs
• Assist with establishing and maintaining the Quality Systems document style guide
• Create clear, detailed, and visually well-designed documents using various MS Office applications such as Word, Excel, Power Point, etc
• Analyze document changes for completeness and alignment with change history. Verify own work, check format and compliance with document templates
• Assist with GxP change control documentation and collaborate with process owners and stakeholders
• Perform advanced word processing support and assist personnel in resolving complex document format issues
• Using project management tools such as Smartsheets to track the progress of document development and other associated projects
• Compile and organize feedback data with accuracy
• Manage and maintain document retention and retrieval of documents
• Demonstrate consistent attention to detail and excellent writing and grammar acumen
  
  

Education/Experience/Skills

• Bachelor’s degree; or an equivalent combination of education and experience
• 5+ years of Document Control Experience
• Strong understanding of QMS and Good Documentation Practices per 21 CFR requirements
• Experience with Veeva Quality Docs system for document lifecycle process purposes and overall functional/system knowledge
• Advanced understanding of using MS Word, Excel, PowerPoint, and Outlook
• Excellent attention to detail and ability to multi-task in a fast-paced hyper-growth environment
• Excellent written and verbal communication skills
• Demonstrated ability to plan and manage multiple tasks/projects
• DSCSA documentation experience is a plus
  
  

EEO Statement

Catalyst Pharmaceuticals is an Equal Opportunity Employer committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status.

Recruitment & Staffing Agencies

Catalyst Pharmaceuticals does not accept unsolicited agency resumes. Agency resumes will only be accepted if the agency is formally engaged by Catalyst Human Resources.