Louise Marsalis

Thorough Quality Engineer adept at performing quality inspections and identifying root causes for non-conforming material issues. Hardworking and meticulous with a passion for continuous improvement.

• Create Incoming Inspection program for Xellia CLE location.
• Contributed to the success of Qualifying Clean Utilities (WFI, Clean Steam, and Nitrogen) for use in facility, met deadline.
• Hire and train in-process inspection, in-coming receiving inspection, metrology, and finished product QA Auditors.
• QE for new product development team, write production, test protocols, inspection plans, validation protocols (IQ, OQ, PQ), supplier agreements, negotiate with customers on product specifications, and customer QA agreements.
• Created QMS for complaint program to track, trend, and log complaints. Wrote test method protocols to facilitate complaint investigation and report writing.
• Leaned out process to meet customer expectations and reporting requirement deadlines per FDA.
• Six Sigma Black Belt project was to design and create QMS to handle the testing, release, and distribution of sterile product. Lean out the release testing requirements.
• Lean out the process flow and handling of the product. Results of project reduced handling costs and resources required for release of product.
• Appointed to the companies Lean Leader program to contribute to cost reduction, resource allocation, and safety teams. Company goals were met.
• Work with Japan, German, Belgium, and Israel suppliers on quality testing requirements with regards to in-coming inspection of supplied components.
• Worked with supplier to resolve quality issues and to reduce waste of product due to testing at in-coming.
• Lead for several FDA, ISO-13485, ISO-9001, Red Cross audit.
• Conducted supplier audits and due diligence audits.
• Worked with Corporate QA on global initiatives for quality assurance to harmonize product testing and customer expectations for product no matter where product was manufactured or distributed from.
• MRB coordinator responsible for investigation into non-conforming product and CAPA. Write reports to customer and complete closure of reports and investigation per quality agreement with customer.
• Train new employees on cGMP requirements. Conduct cGMP training annually to all employees.
• Participated in and wrote Design Verification, Design Review, and Design Transfer documents.

• Six Sigma Black Belt - October 2012
• PDA Training class for Visual inspection of Filled Drug Product
• Effective Complaint Handling- Medical Device Reporting and Recalls
• Stability Program for Pharmaceuticals
• Certified Quality Auditor