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QC Technical Writer
2 months ago
- Support Laboratory Quality Systems including change control, investigations, deviations, events, SOP revisions, and documentation practices as part of the quality and compliance objectives.
- Conduct investigations related to quality systems such as deviations, events, NCRs, CAPAs, OOS, NOEs, complaints, and Quality Protocols of high complexity; works closely with other members of the organization during investigations to determine root cause and potential preventative/corrective actions.
- Author and review investigations and proposed CAPAs, investigational protocols and reports ensuring conclusions and actions are appropriate for the identified root cause.
- Responsible for the timely closure of investigations and quality records and filing extensions as needed
- Author and review stability protocols and reports, Analytical protocols and reports, SOPs, audit responses, and other documents as needed.
- Support review of analytical methods and specification creation and revisions
- Guide assigned personnel in conducting thorough, compliant laboratory investigations.
- Coordinates with QC laboratory personnel
- Provide weekly summaries of lab incidents and investigations to the Senior Manager and Director.
- Communicate activities and status on laboratory investigations as required.
- Responsible for improving and conducting training in analytical techniques, documentation, and regulations, especially those connected with laboratory investigations.
- Handles and completes special projects as required.
- Ensure Data Integrity.
- Supports attainment of team leader goals
- Work with Microsoft Excel, Word, and possibly PowerPoint
- Participate in document change control process as needed to maintain document audit readiness/compliance.
- Working with laboratory CAPA owners to ensure that quality records remain current and present updates at Quality Council meetings.
- Process document changes and management of changes while ensuring good documentation practices (GDP) within the eQMS system.
- Other duties as assigned.