Experience

Redica Systems

• United States
• Information Services
• 1 - 100 Employee

• Regulatory Compliance Associate

  • Feb 2022 - Present

  Responsible for performing global regulatory intelligence activities, such as monitoring, acquiring, tracking, and categorizing information pertaining to the changing global regulatory landscape within the Life Science industry. Participate in shaping the automation, tools, and processes supporting regulatory intelligence operations. Knowledgeable in quality compliance, regulatory intelligence, and structuring and analyzing compliance data. Coordinate with cross-functional teams to… Show more Responsible for performing global regulatory intelligence activities, such as monitoring, acquiring, tracking, and categorizing information pertaining to the changing global regulatory landscape within the Life Science industry. Participate in shaping the automation, tools, and processes supporting regulatory intelligence operations. Knowledgeable in quality compliance, regulatory intelligence, and structuring and analyzing compliance data. Coordinate with cross-functional teams to ensure completion of assigned projects. Research and define data requirements from new data sources. Define and refine quality system models to label and standardize the data. Collaborate with data engineers and data QA to ensure a streamlined data pipeline. Show less Responsible for performing global regulatory intelligence activities, such as monitoring, acquiring, tracking, and categorizing information pertaining to the changing global regulatory landscape within the Life Science industry. Participate in shaping the automation, tools, and processes supporting regulatory intelligence operations. Knowledgeable in quality compliance, regulatory intelligence, and structuring and analyzing compliance data. Coordinate with cross-functional teams to… Show more Responsible for performing global regulatory intelligence activities, such as monitoring, acquiring, tracking, and categorizing information pertaining to the changing global regulatory landscape within the Life Science industry. Participate in shaping the automation, tools, and processes supporting regulatory intelligence operations. Knowledgeable in quality compliance, regulatory intelligence, and structuring and analyzing compliance data. Coordinate with cross-functional teams to ensure completion of assigned projects. Research and define data requirements from new data sources. Define and refine quality system models to label and standardize the data. Collaborate with data engineers and data QA to ensure a streamlined data pipeline. Show less



VaLogic Bio

• United States
• Biotechnology Research
• 1 - 100 Employee

• Quality Services Manager

  • Sep 2021 - Jan 2022

  •Establish Quality Culture through ongoing development and maintenance of VaLogic’s Quality System, including but not limited to Training, Documentation, Deviation Investigation and CAPA, Change Control, Validation, Metrics, and Self Audits. •Provide Quality and Compliance support for all areas of GxP. •Develop processes to ensure company products and services meet quality standards. •Monitor and evaluate internal standard operating procedures and processes. •Oversee employee… Show more •Establish Quality Culture through ongoing development and maintenance of VaLogic’s Quality System, including but not limited to Training, Documentation, Deviation Investigation and CAPA, Change Control, Validation, Metrics, and Self Audits. •Provide Quality and Compliance support for all areas of GxP. •Develop processes to ensure company products and services meet quality standards. •Monitor and evaluate internal standard operating procedures and processes. •Oversee employee performance and inspect product to ensure conformity. •Collaborate with project leaders to discuss solutions to quality issues, investigate causes of quality problems and propose solutions.

• Quality Assurance Specialist

  • Jan 2018 - Jan 2022

  • Trained to manage SOPs, Methods, Work Instructions, and Specifications, as well as Deviations, CAPAs, Audits, Change Controls and Complaints. • Conducts reviews of GMP documents (i.e. Raw Date Reports, IQ/OQ/PQ Protocols, Test Reports, Forms, etc.), both internal and external, to ensure compliance with cGDP and cGMP regulations as established by the FDA, USP, ISO, internal procedures, and other regulatory guidance. • Audits established processes to ensure both internal and external… Show more • Trained to manage SOPs, Methods, Work Instructions, and Specifications, as well as Deviations, CAPAs, Audits, Change Controls and Complaints. • Conducts reviews of GMP documents (i.e. Raw Date Reports, IQ/OQ/PQ Protocols, Test Reports, Forms, etc.), both internal and external, to ensure compliance with cGDP and cGMP regulations as established by the FDA, USP, ISO, internal procedures, and other regulatory guidance. • Audits established processes to ensure both internal and external regulations and standards are being adhered to. • Provide insight to improve processes and practices to ensure manufacturing quality is maintained while efficiency is optimized. • Conduct staff training on quality procedures, protocols, and documentation to ensure compliance to cGMP requirements. • Provide maintenance and control of Quality Assurance documentation • Conduct investigation when measurements are found to deviate from standards • Drafting Standard Operating Procedures (SOPs) for the manufacturing process, environmental monitoring, and in compliance with CFR. • Ensuring auditing and manufacturing documentation is kept up to date • Release and control of raw material for GMP use, ensuring separation of quarantines and released material. • Provide compliance guidance to clients.



VaLogic Bio

• United States
• Biotechnology Research
• 1 - 100 Employee

• Validation Technician Senior

  • Jun 2012 - Jun 2014

  • Tests, monitors and evaluates machinery, equipment and processes to ensure conformity to validation criteria. • Participate in cGMP training and adhere to in-house and client-specific SOPs • Performs thermal mapping studies of various equipment, utilizing Kaye Validators and associated software. • Generates reports of the thermal mapping studies and applies them to the execution of protocols. • Knowledgeable in the use of electronic multi-meters for measuring voltages and… Show more • Tests, monitors and evaluates machinery, equipment and processes to ensure conformity to validation criteria. • Participate in cGMP training and adhere to in-house and client-specific SOPs • Performs thermal mapping studies of various equipment, utilizing Kaye Validators and associated software. • Generates reports of the thermal mapping studies and applies them to the execution of protocols. • Knowledgeable in the use of electronic multi-meters for measuring voltages and amperage. • Prepared protocols and reports for validation work. • Coordinate validation activities by constant communication with affected departments and personnel. • Organize and consolidate client records and files. • Perform data entry and update various databases. Show less • Tests, monitors and evaluates machinery, equipment and processes to ensure conformity to validation criteria. • Participate in cGMP training and adhere to in-house and client-specific SOPs • Performs thermal mapping studies of various equipment, utilizing Kaye Validators and associated software. • Generates reports of the thermal mapping studies and applies them to the execution of protocols. • Knowledgeable in the use of electronic multi-meters for measuring voltages and… Show more • Tests, monitors and evaluates machinery, equipment and processes to ensure conformity to validation criteria. • Participate in cGMP training and adhere to in-house and client-specific SOPs • Performs thermal mapping studies of various equipment, utilizing Kaye Validators and associated software. • Generates reports of the thermal mapping studies and applies them to the execution of protocols. • Knowledgeable in the use of electronic multi-meters for measuring voltages and amperage. • Prepared protocols and reports for validation work. • Coordinate validation activities by constant communication with affected departments and personnel. • Organize and consolidate client records and files. • Perform data entry and update various databases. Show less