YODAHE ZEGEYE

• Prepared and executed special studies upon approval of study request
• Managed all aspects of study close-out, ensuring timely delivery of final reports for future reference or regulatory inspection purposes.
• Facilitated and monitored progress of change throughout process to ensure Change Control Request (CCR) is completed within expected time frame
• Performed assessment for impacted Routine/Special study (and amended protocols to ensure changes are implemented in timely manner
• Expedited project timelines through effective prioritization and delegation of tasks among team members.
• Maintained organized and efficient document flows by using excellent planning and multitasking skills.
• Organized routine meetings to facilitate effective communication and collaboration regarding documentation updates.
• Managed multiple high-priority projects simultaneously, ensuring that all deadlines were met without compromising document quality.

• Supported Stability and Sample Management Managers with daily administrative tasks
• Generated and compiled temporary reports from LIMS system as per Annual product quality report (APQR) period and resolved linking issues
• Drafted special stability study protocols upon approval of study request
• Updated SOPs and protocols for administrative changes/change controls.

Prepared laboratory equipment and instrumentation required for experiments and researches

• Prepared samples for centrifugation, aliquoting and preserving sample integrity.
• Maintained safe environment by ensuring volatile and flammable compounds are placed in fume hood and that substances (solutions) are labeled
• Maintained inventory and equipment and placed orders for laboratory supplies
• Handled administrative tasks for laboratory staff and overall operations
• Used time management and adaptability skills to prioritize and run multiple tests.