
Documentation Specialist
7 hours ago
This is a challenging opportunity for an experienced Documentation Specialist to join our team in a hybrid role.
The successful candidate will be responsible for:
- Developing, implementing and maintaining documentation procedures in line with site requirements.
- Serving as document owner.
- Preparing and delivering training materials and providing technical support on scientific or technical aspects of the process.
- Liaising effectively with cross-functional teams to ensure timely and accurate documentation changes.
- Collaborating with Operations lead and SMEs to develop protocols for execution in Manufacturing & Inspection in support of change controls, non-conformances and troubleshooting investigations.
- Providing technical and administrative support to the manufacturing, inspection and engineering teams in the preparation of documentation, data collection and tracking of SOPs.
- Ensuring Non-conformance are triaged within established goals and serving as deviation owner for minor deviations.
- Owning corrective/preventative actions and effectiveness verification.
Key responsibilities include ensuring GMP standards are maintained in accordance with current OS, developing and maintaining all relevant documentation including SOPs, compiling and maintaining paper batch records in line with production schedule, and liaising with Quality Assurance to ensure compliance with regulatory requirements.
Additional tasks may include:
- Performing document trending upon project completion to identify key issues/mistakes in document processing.
- Supporting data verification of Operations owned protocols reports and risk assessments.
- Reducing document turnaround times through collaboration with the production support team.
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