What are the responsibilities and job description for the Quality Control Documentation Specialist position at Course?
The Quality Control Documentation Specialist is responsible for performing the data review for the release of regulated and / or non-regulated materials including raw materials, in-process and finished products under general supervision and in accordance with standard operating procedures (SOPs). The incumbent will maintain the Quality Control document system, paper and electronic, including but not limited to : Laboratory notebooks, logbooks, controlled forms, and electronic data. They may also compile data and prepare reports for the purpose of trending or support for investigative purposes.
Responsibilities
- Review batch data for release of GMP / ISO and / or non-regulated materials by ensuring the product meets set standards
- Review data, including raw data, laboratory notebooks, logbooks, and forms, for completeness and accuracy, including audit trails and electronic data
- Train on and follow documented procedures under GMP guidelines
- Compile data for trending purposes (i.e. cycle times)
- Author or edit test procedures and SOPs
- Support investigation team by compiling or reviewing related data
- Prepare summary or trend reports
- Write deviation, CAPA reports, including root cause analysis and implementing appropriate corrective actions
- Track and maintain laboratory notebooks, logbooks, controlled forms, spreadsheets, training records, and other QC related documents
- Train others on practices of data review and documentation
Requirements
