Experience

Regeneron

• United States
• Biotechnology
• 700 & Above Employee

• Contract Technical Writer

  • Aug 2023 - Present



Fagron Sterile Services US (FSS)

• United States
• Pharmaceutical Manufacturing
• 100 - 200 Employee

• Deviation/Investigation writer

  • Jan 2021 - Present

  • Responsible for documenting deviations while gathering, analyzing, and applying information from internal and external sources in order to perform a risk assessment of the impact each process deviation and complaint has on the product, process, and patient health and safety. • As part of each investigation, gather information from all necessary internal and external sources to evaluate the impact of the deviation on the previously manufactured products and the risk to future operations. • Prepares and analyzes manufacturing and laboratory analytical historical data and uses methodical root-cause analysis tools to determine root causes and effectively communicates the root cause to management. • Assess the manufacturing or analytical environment, independently conceive, and advise management on appropriate corrective/preventative actions designed to mitigate Quality deficiencies identified in the investigative process using industry-accepted analytical tools. • Responsible for documenting Change Controls and coordinating with the Manufacturing and Quality Assurance team to develop change control procedures and train users on the required SOPs. Show less



Catalent Pharma Solutions

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Technical Writer

  • Aug 2019 - Dec 2020

  • Perform all activities as per current standard procedures by referring to all approved procedures/specifications to ensure compliance with cGMP and safety norms. • Train on all standard operating procedures (SOPs) essential for cGMP. • Ensure that data integrity and security are maintained based on the principles of ALCOA (Attributable, Legible, Contemporaneous, Original, and Accurate). • Document deviations and ensure they’re reviewed and analyzed. Recommend studies, tests, new procedures or validation activities to be performed. • Performed investigations into the cause of the issue, provide an investigation report, and collaborate to determine appropriate (Corrective and Preventive Actions) CAPAs to mitigate the root cause. • Reviewed batch Production Records & Standard Manufacturing Procedures and interviewed operators involved with deviations. • Integrate Quality Management Systems utilizing Trackwise for Vendor management deviations, Corrective and Preventive Actions (CAPA). Show less