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Bioprocessing Operations Specialist
hace 1 mes
We are seeking an experienced Bioprocessing Operations Specialist to join our team at BioPharma Consulting JAD Group. The ideal candidate will have a strong background in bioprocessing unit operations and GMP production, as well as excellent organizational, technical writing, and presentation skills.
Key Responsibilities:
- Process Expertise:
- Serve as a document owner by initiating, revising, and approving manufacturing procedures.
- Assess floor operations and performance data to identify and implement process improvements.
- Provide troubleshooting support and assist in developing training materials for technical aspects of processes.
- Process Monitoring:
- Support establishment of process parameters and control limits; collect data to monitor processes and assess deviations.
- Assist with timely preparation of process monitoring reports.
- Non-Conformance & CAPA Management:
- Triage and document non-conformances and CAPA within established timelines.
- Author investigation reports, execute corrective actions, and manage NC/CAPA closures.
- Support root cause analysis evaluations and trend monitoring for continuous improvement.
- Process Validation:
- Assist in creating and executing process validation protocols and reports.
- Support data collection and analysis for validation activities.
- Regulatory Compliance:
- Participate in regulatory inspections as needed to ensure all protocols meet compliance standards.
- New Product Introductions & Process/Equipment Modifications:
- Contribute to NPI efforts by assessing requirements for documentation, materials, and training.
- Provide project management support for process and equipment modifications.
- Change Control and Special Projects:
- Assist in change control management, supporting CCRB packages impacting processes.
- Engage in special projects or initiatives as assigned.
