Category: Scientific & Clinical
Job Title: Documentation Specialist-Analyst II
Location: Rockville, MD
A leading biotech company in Rockville, MD is seeking a Document Specialist. For immediate consideration please email your resume to Senior Recruiter Ivy Fairfax at email@example.com.
- Provide oversight and support of documentation and records management for the site using company procedures and regulations.
- Ensure CAPAs and CCs are addressed and closed timely relating to manufacturing, technical operations and quality control for the Fill and Finish Facility.
- Support efforts for continuous improvement in deviation and CAPA reduction as well as manufacturing operations for the site.
- Support completion of department operational tasks related to record and document revision, creation, processing.
- Work closely with various departments to understand requirements for documentation revisions.
- Create new SOPs, forms, protocols, reports and edit existing documents as necessary. Format the current documents to the company required format utilizing Microsoft Word and the Veeva system.
- Independently gather information from subject matter experts to develop, organize, and revise SOPs and other documents.
- Review and compile documentation to assist with deviation investigations. Complete and close CAPA and CC effectiveness checks.
- Complete CAPA and CC deliverables and close associated tasks utilizing the SAP system
- Author and execute tasks for document revisions, deviations, CAPAs, and change controls related to all departments.
- Compile and report performance metrics for quality systems. Participate on response teams to address observations and recommendations made during inspections.
- Identify opportunities for improvement within scope of work.
- BS degree or equivalent level of skill and experience.
- 2-4 years of experience with electronic document management (Veeva experience preferred), deviation, CAPA, and change control systems (SAP experience preferred) in a GMP, FDA regulated environment
- Microsoft Office Specialist certification, Records management experience, Configuration management experience preferred