Experience

Biovalorem

• United States
• Biotechnology
• 1 - 100 Employee

• GxP Compliance Consultant

  • Aug 2022 - Present

  ▪ Prepare and modify Quality Management System deliverables such as Quality Manuals, Standard Operating Procedures and/or Working Instructions ▪ Manage client-controlled documents, standard operating procedures, training status, issues and change control, issues and investigations, etc. ▪ Facilitate and track quality system related training of client employees ▪ Coordinate and/or conduct of GxP audits, evaluation of audit findings, and tracking of appropriate corrective… Show more ▪ Prepare and modify Quality Management System deliverables such as Quality Manuals, Standard Operating Procedures and/or Working Instructions ▪ Manage client-controlled documents, standard operating procedures, training status, issues and change control, issues and investigations, etc. ▪ Facilitate and track quality system related training of client employees ▪ Coordinate and/or conduct of GxP audits, evaluation of audit findings, and tracking of appropriate corrective actions ▪ Monitor and update qualification status of vendors on behalf of clients ▪ Support and/or perform batch review and device master records, record and log as required ▪ Perform and record process and/or computer system validation activities ▪ Review and approve new client product labelling ▪ Coordinate and record quarterly management review meetings of clients ▪ Leverage Sharepoint, Docusign and other document management system to design validated client Quality Management Systems Show less



enGene

• Canada
• Biotechnology Research
• 1 - 100 Employee

• Quality Assurance Manager

  • Apr 2021 - Aug 2022

  Montreal, Quebec, Canada ▪ Implemented and oversaw the compliance of the Quality Management System (QMS) to the applicable regulations and industry standards Standard Operating Procedures ▪ Implemented and managed the Change control process ▪ Establish sustainable process for Supplier Corrective Action Reporting ▪ Oversaw and maintained the risk-based vendor management program via the conduct of GxP audits, audit reports, findings criticality assessment and follow ups on the resulting… Show more ▪ Implemented and oversaw the compliance of the Quality Management System (QMS) to the applicable regulations and industry standards Standard Operating Procedures ▪ Implemented and managed the Change control process ▪ Establish sustainable process for Supplier Corrective Action Reporting ▪ Oversaw and maintained the risk-based vendor management program via the conduct of GxP audits, audit reports, findings criticality assessment and follow ups on the resulting CAPAs. ▪ Disposition of GMP investigative medicinal product through reviewed and approval of Manufacturing Batch Records for drug substance, drug product and finished goods. ▪ Routine quality reviews with executive management to ensure understanding of status and organizational quality needs ▪ Supply chain oversight to ensure alignment of CMC needs for Drug Substance, Drug product, stability program etc. ▪ Regulatory reviews and verifications of pre-Clinical reports and Manufacturing reports for IND Phase 1 Submission to the FDA. ▪ Oversaw and maintained the company SharePoint QMS site

• Quality Assurance Responsible

  • Aug 2017 - Mar 2021

  Montreal, Canada Area ▪ Prepared controlled documents, standard operating procedures, to ensure QMS compliance ▪ Maintained all aspects of training program to ensure compliance ▪ Oversaw the archiving system of the company for internal pre-clinical and external GxP documentation. ▪ Reviewed and compiled all batch-related documentation such as CoAs, Specifications, Batch Records, Deviations, CAPAs, OOS, Change Requests, etc. to prepare for lot disposition. ▪ Planned, conducted, and reported vendor audits… Show more ▪ Prepared controlled documents, standard operating procedures, to ensure QMS compliance ▪ Maintained all aspects of training program to ensure compliance ▪ Oversaw the archiving system of the company for internal pre-clinical and external GxP documentation. ▪ Reviewed and compiled all batch-related documentation such as CoAs, Specifications, Batch Records, Deviations, CAPAs, OOS, Change Requests, etc. to prepare for lot disposition. ▪ Planned, conducted, and reported vendor audits ▪ Compiled quality-related data and performed review of the company annual Quality Management Review.



Fresenius Medical Care North America

• United States
• Hospitals and Health Care
• 700 & Above Employee

• Documentation Specialist

  • May 2009 - Aug 2017

  ▪ Managed the lifecycle of documentation such as standard operating procedures, forms, change control, CAPAs, etc. ▪ Prepared production master documents. ▪ Reviewed executed batch records for release. ▪ Released finished product in SAP per QA manager instructions. ▪ Supported in the implementation and management of an electronic learning management system - ComplianceWire. ▪ Supported Health Canada and FDA inspections