I have hands-on experience operating and monitoring bioreactors, ensuring optimal conditions for cell growth and product formation. I am proficient in setting up, calibrating, and maintaining bioreactor systems, as well as troubleshooting any issues that arise. My role involved closely monitoring parameters such as pH, temperature, dissolved oxygen, and agitation rates to maintain process consistency and product quality. I also documented all activities and results meticulously to ensure compliance with regulatory standards.

I ensure compliance with GMP by strictly adhering to standard operating procedures (SOPs) and maintaining accurate documentation. I regularly participate in training sessions to stay updated on GMP regulations and best practices. In my previous role, I conducted routine audits and inspections to identify and rectify any deviations from GMP standards. I also emphasized the importance of cleanliness, proper equipment calibration, and accurate record-keeping to maintain a controlled and compliant manufacturing environment.

When troubleshooting a process deviation, I first identify the root cause by analyzing data and reviewing process parameters. I then implement corrective actions, such as adjusting process conditions or recalibrating equipment, to bring the process back on track. Communication with the team is crucial, so I ensure all relevant personnel are informed and involved in the resolution process. Finally, I document the deviation, the steps taken to address it, and the outcome to prevent recurrence and ensure continuous improvement.

I handle documentation and reporting by maintaining detailed and accurate records of all processes, experiments, and results. I use electronic systems and logbooks to ensure data integrity and traceability. I am meticulous in following SOPs for documentation, ensuring that all entries are timely, clear, and compliant with regulatory requirements. Regular reviews and audits are part of my routine to verify the accuracy and completeness of the documentation, which is essential for quality control and regulatory submissions.

I have extensive experience with cell culture, including the preparation, maintenance, and expansion of cell lines. I am skilled in aseptic techniques to prevent contamination, such as working in laminar flow hoods and using sterile equipment. My role involved monitoring cell viability, density, and growth rates, as well as optimizing culture conditions to enhance productivity. I also performed routine media changes, passaging, and cryopreservation, ensuring the integrity and viability of the cell cultures throughout the process.