Documentation Specialist
1 week ago
Join bioMerieux, a leading company in the field of in vitro diagnostics, as a Documentation Specialist. In this role, you will play a critical part in supporting site operations, project development, and change management processes. Your primary responsibilities will include creating and maintaining Standard Operating Procedures (SOPs) and Manufacturing Directions (MDs), participating in planning and implementation of documentation deliverables, and communicating effectively with internal customers and management.
Key Responsibilities:- Create and maintain SOPs and MDs as a member of project and functional teams.
- Participate in planning, scheduling, and implementation of documentation deliverables for Nonconformances (NCs), Corrective Actions/Preventive Actions (CAPAs), and Process Improvements.
- Communicate effectively and accurately with internal customers and management to ensure timelines are met and documentation is accurate and easy to understand.
- Participate in project planning activities, assessing necessary resources, and estimating timelines for documentation development and production.
- Research, write, and format user documentation according to approved styles and standards. Proofread documentation for accuracy and adherence to approved styles and standards.
- Compile reports, spreadsheets, and documentation as needed to support departmental workflow.
- Communicate with internal review teams to obtain approvals necessary for Change Requests.
- Track and implement change requests.
- Regularly interface with QA, QC, Manufacturing, Engineering, and other personnel to ensure that documentation concerns are timely resolved.
- Assist Quality Engineers in collection of paperwork for nonconformance investigations.
- Bachelor's Degree preferred with 0 years Documentation experience in FDA regulated industry OR High School Diploma or GED with 3+ years Documentation experience in FDA regulated industry.
- Basic Computer Skills required; must be experienced and proficient in the use of: Microsoft Office tools (specifically Word & Excel). Advanced use of MS Word preferred.
- Excellent documentation and communication skills (written & verbal).
- Position requires strong attention to detail, GDP and GMP experience.
- Ability to work successfully autonomously, as an active contributor on a team.
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