Alexa Carapella

• Manage the day-to-day activities within Biologics (US), part of Therapeutic Development & Supply organization

Key Responsibilities:

• Create new employees on boarding, training, and access within Summit, on average around25 new employees each month
• Update and create curriculum for training materials within Summit
• Updating and maintaining department SOPs in Veeva Vault system
• Ensures procedural documents within TruVault (SOPs, WIs, etc) are reviewed and updated periodically per established timelines
• Pull monthly reports through QtSoQ (Quantify the State of Quality) such as records coming due, root causes, QEM reports created, and overview
• Assisted during internal and external audits by providing reports, SOPs, and compiling pre-requests
• Support SME for all compliance related issues and in collaboration with quality team
• Conducted thorough research to develop innovative solutions for complex scientific problems.
• Improved experimental protocols by meticulously analyzing data and adjusting methodologies.
• Enhanced accuracy of results with precise data collection and analysis techniques.
• Collaborated with multidisciplinary teams to advance research objectives and foster innovation.

• Manage the day-to-day activities of the Quality Assurance Laboratory Controlled Worksheet support unit

Key Responsibilities:

• Updating and issuing Laboratory Test Worksheet, updating anywhere from a hundred to over a thousand a day
• Routing associated change control documentation for approvals, routed around fifty per week depending on requests
• Updating and maintaining every change control in Midas, Veeva Vault, and Mylearning
• Compilation of Controlled Worksheet and Supplies Inspection protocol related metrics
• Ensure high level of compliance and always maintain Inspection/Audit and GMP readiness
• Compiles and distributes weekly/monthly/quarterly IQN reports
• Collaborated with departments to implement compliance programs, enhancing organizational integrity.
• Provide Process Improvements
• Coordinated audits to ensure compliance with regulatory standards.
• Reviewed documentation for accuracy and alignment with compliance requirements.

• Manage the day-to-day activities of the Quality Assurance Laboratory Controlled Worksheet support unit

Key Responsibilities:

• Updating and issuing Laboratory Test Worksheet, updating anywhere from a hundred to over a thousand a day
• Routing associated change control documentation for approvals, routed around fifty per week depending on requests
• Updating and maintaining every change control in Midas, Veeva Vault, and Mylearning
• Compilation of Controlled Worksheet and Supplies Inspection protocol related metrics
• Ensure high level of compliance and always maintain Inspection/Audit and GMP readiness
• Compiles and distributes weekly/monthly/quarterly IQN reports
• Collaborated with departments to implement compliance programs, enhancing organizational integrity.
• Provide Process Improvements
• Coordinated audits to ensure compliance with regulatory standards.
• Reviewed documentation for accuracy and alignment with compliance requirements.
• Strengthened client relationships by addressing inquiries and resolving concerns promptly.

• Supplied and supported the labs within Global Clinical Immunology group

Key Responsibilities:

• Maintained, updating and archiving all GCI generated raw data and laboratory support documentation (over a thousand logbooks)
• Creating and inactivating all training courses, modules, and employee profiles
• Performed audits in a timely manner using Sanofi Pasteur SOP’s and work instruction
• Assisted during internal and external audits by providing training records and reports
• Determination of randomizations of data for audit
• Expert knowledge of ISOtrain, Edoc, LIMS, LIMS link, Microsoft word excel, and outlook
• Document all discrepancies and distribute to various personnel for discrepancy resolution
• Supported training and Quality audits
• Facilitated smooth day-to-day operations by anticipating needs, proactively addressing potential issues, and efficiently resolving problems as they arose.