Documentation Specialist
4 weeks ago
We are seeking a highly skilled Documentation Specialist to join our team at bioMerieux. As a key member of our site operations team, you will play a critical role in supporting project development, change management, and documentation associated with products manufactured at our Durham site.
Key Responsibilities- Create and maintain Standard Operating Procedures (SOPs) and Manufacturing Directions (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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Documentation Specialist
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Durham, North Carolina, United States bioMerieux Full timeJob Title: Documentation SpecialistAt bioMerieux, we are seeking a highly skilled Documentation Specialist to join our team. As a key member of our site operations project development team, you will play a critical role in supporting the development, implementation, and maintenance of documentation associated with products manufactured at our Durham site.Key...
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