ANTONELLA MAGGIOLO

• Perform investigations for customer product complaints
• Work closely with the engineering, QC and micro lab departments to determine root-cause
• Review of documentation, including but not limited to batch record review, CofA, AQL inspections, etc
• Perform data analysis to identify trends and propose improvements where needed
• Assist in external and internal audits
• SOP revision as needed

• Execution of investigations, to determine the root cause of quality product complaints and deviations
• Perform retain inspections and testing of customer returned samples to identify defects and perform root cause analysis
• Work closely with the QC and R&D team to perform tests on product retains or returned products for investigations
• Develops and defines appropriate CAPAs to correct or prevent similar occurrences
• Identifies adverse product or complaint trends through trending and metrics to inform management
• Lead investigation (deviations) activities by gathering information from internal and external sources to resolve root cause, evaluate product impact, evaluate risk to previous or future batches and develop effective CAPAs
• Performs SOP revisions to reflect current good manufacturing practices
• Perform APQR for dispositions, deviations and CAPAs, product quality complaints

• Review batch records, CofAs and related documents; cross-check against specifications for accuracy, completeness, and contemporaneousness
• Reconciliation of labels and other components
• Performs final disposition of finished good product (release/reject)
• Identify and initiate deviations
• Performs issuance and reconciliation of controlled forms
• Works closely with production functional teams to align and promote awareness on data integrity and current good documentation practices and assists with corrections

• Investigate and disposition of non-conforming materials from different product lines to ensure reports are completed in a timely manner
• Attends daily material review board meetings to represent the non-conformance group and works closely with the engineering department
• Maintain weekly inventory of quarantine area and ensuring all inventory needs are met by consistently improving inventory management
• Assisting materials group with returning material back to vendor to coordinate movement of parts

• Approval of production line prior to starting by confirming specifications, reviewing components, conducting inspections and tests, communicating required adjustments to production supervisor
• Performed hourly inspection checks on product quality during in-process of production
• Accurately document results of hourly inspections and tests
• Approval of controlled labels for production
• Performs line clearance

• Perform compliance and quality assurance reviews by conducting QC documentation review
• Maintain current knowledge base of existing and emerging regulations, standards, or guidance documents
• Prepare or direct the preparation of additional information or responses as requested by customers
• Communicated with customers regarding deadlines, services, audit results, reviews, or clarification and follow-up of submissions under review
• Recommended changes to company procedures in response to changes in regulations or standards
• Performed visual inspection on finished good products

Currently attending