Senior Scientific Manager, Product Support

• Jan 2023 - Present

Scientific Manager, Product Support

• Mar 2021 - Feb 2023

• As a member of the R&D leadership team, reporting to site head of R&D, served as team lead for the IVDR project. • Oversights of design history file maintenance and uplift development activities. Plan, organize, and supervise R&D activities related to product development for on-market products. Provide technical input/direction for on-market products and design studies to meet appropriate performance, quality, and regulatory, etc. standards. • Collaboration with other departments… Show more • As a member of the R&D leadership team, reporting to site head of R&D, served as team lead for the IVDR project. • Oversights of design history file maintenance and uplift development activities. Plan, organize, and supervise R&D activities related to product development for on-market products. Provide technical input/direction for on-market products and design studies to meet appropriate performance, quality, and regulatory, etc. standards. • Collaboration with other departments within the site/company to maintain and improve product design, and with Project Management and various departments to build project schedules to ensure deadlines are met. • Collect, analyze and interpret data from development testing, QC testing, and Complaints as applicable to ensure that products meet all specifications. • Provide technical support to Quality department for material OOS investigations, data analysis, and product improvement.

R&D Scientist

• Oct 2019 - Mar 2021

• Part of a team focusing on legacy products to be uplifted for the In Vitro Diagnostic Regulation (IVDR) (EU) 2017/746. Tasks included product testing for IVDR alignment: sensitivity & specificity, accelerated stability, and reproducibility & repeatability testing. Performed gap analysis for device history file, report and document generation, and review of product optimization. Complete all work in compliance with established cGMP, FDA, OSHA, USDA, EPA, ISO and Quality System regulations… Show more • Part of a team focusing on legacy products to be uplifted for the In Vitro Diagnostic Regulation (IVDR) (EU) 2017/746. Tasks included product testing for IVDR alignment: sensitivity & specificity, accelerated stability, and reproducibility & repeatability testing. Performed gap analysis for device history file, report and document generation, and review of product optimization. Complete all work in compliance with established cGMP, FDA, OSHA, USDA, EPA, ISO and Quality System regulations, as applicable, to assure output meets established quality and regulatory specifications • Tasked with coordination of project elements to ensure timely submission of R&D deliverables for IVDR registration. Cross-functional collaboration with Quality, Regulatory, Commercial, and project management for establishment of project cadence, review of auditor responses and update of required policies, procedures, and documents as needed. • Develop, write and update documents pertaining to lab procedures and product manufacturing to maintain cGMP and ISO compliance. Write lab reports or project summaries as requested. • Ownership of Trackwise change control, deviation and CAPA records assigned to R&D for on-market products

Quality Assurance Specialist

• Aug 2017 - Oct 2019

• Lead investigator and subject matter expert for product quality complaints (performance, labeling, packaging, etc.). • Investigation tasks include review of device history files, manufacturing device records and IHC testing of products to determine root cause of device error. • Risk assessment of potential product performance trends. • Identification of product non-conformances and CAPA projects. • Provide support for both internal and external… Show more • Lead investigator and subject matter expert for product quality complaints (performance, labeling, packaging, etc.). • Investigation tasks include review of device history files, manufacturing device records and IHC testing of products to determine root cause of device error. • Risk assessment of potential product performance trends. • Identification of product non-conformances and CAPA projects. • Provide support for both internal and external audits. • Development of SOP for quality management systems for complaint investigation process. • New product validation. This includes testing of products per intended use, review of product documentation to ensure accuracy and reporting of results to design review team. • Knowledgeable in various regulatory requirements for a medical device manufacturer, GMP & GDP practices, ISO13485:2016, 21, MDSAP, and CFR 821.198. • Served as site lead user to develop training and implementation of the TrackWise complaints module.

Lab Tech II - Technical Support/Customer Care Specialist

• Feb 2015 - Aug 2017

• Provide technical support and perform troubleshooting in immunohistochemistry (IHC) for domestic customers and international distributors. • Perform necessary testing to determine root cause of product performance complaints. Work collaboratively with QA to set necessary actions for verified complaints. • Manage customer complaints and trouble shooting requests, to include analysis of potential trends, investigation, review with company pathologist and escalation to QA when necessary.… Show more • Provide technical support and perform troubleshooting in immunohistochemistry (IHC) for domestic customers and international distributors. • Perform necessary testing to determine root cause of product performance complaints. Work collaboratively with QA to set necessary actions for verified complaints. • Manage customer complaints and trouble shooting requests, to include analysis of potential trends, investigation, review with company pathologist and escalation to QA when necessary. • Maintain lab, monitor lab inventory and manage equipment folders to ensure routine maintenance and documentation is current. • Experienced in the following immunohistochemistry staining platforms: Ventana Benchmark Ultra, Leica Bond and manual staining. I have an understanding of antibody technology and continue to build my knowledge of their applications for cancer and viral diagnostics. • Perform product validations for new product introductions. • Prepare training presentations and conduct IHC staining training for new customer facing employees and international distributors.

Attendance Clerk

• Jan 2013 - Jun 2014

• Responsible for daily attendance records of 700+ students. Submitted daily reports to Dean of Students to monitor excessive absences and tardy marks, ran reports per class period/teacher to very timely submission and accuracy and examined end of day reports to correct attendance errors. • Fully trained auxiliary Attendance Clerk employee. • Maintained and organized all attendance documents to ensure efficiency, accuracy and preparedness for state audit. Provided requested data and… Show more • Responsible for daily attendance records of 700+ students. Submitted daily reports to Dean of Students to monitor excessive absences and tardy marks, ran reports per class period/teacher to very timely submission and accuracy and examined end of day reports to correct attendance errors. • Fully trained auxiliary Attendance Clerk employee. • Maintained and organized all attendance documents to ensure efficiency, accuracy and preparedness for state audit. Provided requested data and documents as needed by auditors. • Prepared Independent Study Plans for extended student absences, followed up to receive completed documents and class work. • Accountable for compliance with California Education Code, discussed with parents and students as needed to explain attendance policies and procedures. Show less • Responsible for daily attendance records of 700+ students. Submitted daily reports to Dean of Students to monitor excessive absences and tardy marks, ran reports per class period/teacher to very timely submission and accuracy and examined end of day reports to correct attendance errors. • Fully trained auxiliary Attendance Clerk employee. • Maintained and organized all attendance documents to ensure efficiency, accuracy and preparedness for state audit. Provided requested data and… Show more • Responsible for daily attendance records of 700+ students. Submitted daily reports to Dean of Students to monitor excessive absences and tardy marks, ran reports per class period/teacher to very timely submission and accuracy and examined end of day reports to correct attendance errors. • Fully trained auxiliary Attendance Clerk employee. • Maintained and organized all attendance documents to ensure efficiency, accuracy and preparedness for state audit. Provided requested data and documents as needed by auditors. • Prepared Independent Study Plans for extended student absences, followed up to receive completed documents and class work. • Accountable for compliance with California Education Code, discussed with parents and students as needed to explain attendance policies and procedures. Show less

Lab Assistant II

• 2003 - 2006

• Collaborative project for cytogenetic analysis of avian blastodermal cells. • Responsible for chromosome harvests, slide preparation, DAPI staining and chromosome analysis via microscopy. • Prepared PowerPoint presentations of quality chromosome spread images, used to determine variability in count and morphology. • Performed general lab functions such as preparation of reagents, packaging of slide preparations for proper storage, sterilization of glassware and assist research… Show more • Collaborative project for cytogenetic analysis of avian blastodermal cells. • Responsible for chromosome harvests, slide preparation, DAPI staining and chromosome analysis via microscopy. • Prepared PowerPoint presentations of quality chromosome spread images, used to determine variability in count and morphology. • Performed general lab functions such as preparation of reagents, packaging of slide preparations for proper storage, sterilization of glassware and assist research staff/students as needed. • Experimental techniques acquired: BAC DNA isolation/purification, FISH and cell culture. • Development and follow through of the Avian Research Resources Survey II. Updated research stock information and website creation/maintenance. Assisted the PI with preparation of data, documentation and research resources for publication in a text book. Show less • Collaborative project for cytogenetic analysis of avian blastodermal cells. • Responsible for chromosome harvests, slide preparation, DAPI staining and chromosome analysis via microscopy. • Prepared PowerPoint presentations of quality chromosome spread images, used to determine variability in count and morphology. • Performed general lab functions such as preparation of reagents, packaging of slide preparations for proper storage, sterilization of glassware and assist research… Show more • Collaborative project for cytogenetic analysis of avian blastodermal cells. • Responsible for chromosome harvests, slide preparation, DAPI staining and chromosome analysis via microscopy. • Prepared PowerPoint presentations of quality chromosome spread images, used to determine variability in count and morphology. • Performed general lab functions such as preparation of reagents, packaging of slide preparations for proper storage, sterilization of glassware and assist research staff/students as needed. • Experimental techniques acquired: BAC DNA isolation/purification, FISH and cell culture. • Development and follow through of the Avian Research Resources Survey II. Updated research stock information and website creation/maintenance. Assisted the PI with preparation of data, documentation and research resources for publication in a text book. Show less

Office Manager

• 2002 - 2004

• Managed daily operations of small non-profit office. • Reported to the Executive Director with correspondence, staffing and coordination of projects. • Conducted weekly staff meetings and other duties related to management of office personnel. • Provided back up support to accounting assistant, ultimately acquired all accounting duties and became familiar with Business Works accounting software. • Assisted with conference/seminar preparations, on-site registration and… Show more • Managed daily operations of small non-profit office. • Reported to the Executive Director with correspondence, staffing and coordination of projects. • Conducted weekly staff meetings and other duties related to management of office personnel. • Provided back up support to accounting assistant, ultimately acquired all accounting duties and became familiar with Business Works accounting software. • Assisted with conference/seminar preparations, on-site registration and logistics. • Began development of office procedures and accounting procedures manuals. • Occasionally assisted with Executive Committee meetings. Show less • Managed daily operations of small non-profit office. • Reported to the Executive Director with correspondence, staffing and coordination of projects. • Conducted weekly staff meetings and other duties related to management of office personnel. • Provided back up support to accounting assistant, ultimately acquired all accounting duties and became familiar with Business Works accounting software. • Assisted with conference/seminar preparations, on-site registration and… Show more • Managed daily operations of small non-profit office. • Reported to the Executive Director with correspondence, staffing and coordination of projects. • Conducted weekly staff meetings and other duties related to management of office personnel. • Provided back up support to accounting assistant, ultimately acquired all accounting duties and became familiar with Business Works accounting software. • Assisted with conference/seminar preparations, on-site registration and logistics. • Began development of office procedures and accounting procedures manuals. • Occasionally assisted with Executive Committee meetings. Show less

Services Buyer/Staff Accountant

• Jun 1998 - Sep 2000

• Managed requisitions and vendors for promotional/marketing items, temporary services, and consulting services. • Aided in the development of an updated corporate promotional marketing materials line. • Assisted with and resolved aged accounting and invoicing issues, educated clients on procurement policies and procedures. • Conducted quarterly reviews with vendors to develop strong working relationships and assess status of account and products provided. • Recruited to… Show more • Managed requisitions and vendors for promotional/marketing items, temporary services, and consulting services. • Aided in the development of an updated corporate promotional marketing materials line. • Assisted with and resolved aged accounting and invoicing issues, educated clients on procurement policies and procedures. • Conducted quarterly reviews with vendors to develop strong working relationships and assess status of account and products provided. • Recruited to Staff Accountant position in March 2000. Processed invoices for Accounts Payable, performed account reconciliation, and worked with suppliers to resolve billing errors. Show less • Managed requisitions and vendors for promotional/marketing items, temporary services, and consulting services. • Aided in the development of an updated corporate promotional marketing materials line. • Assisted with and resolved aged accounting and invoicing issues, educated clients on procurement policies and procedures. • Conducted quarterly reviews with vendors to develop strong working relationships and assess status of account and products provided. • Recruited to… Show more • Managed requisitions and vendors for promotional/marketing items, temporary services, and consulting services. • Aided in the development of an updated corporate promotional marketing materials line. • Assisted with and resolved aged accounting and invoicing issues, educated clients on procurement policies and procedures. • Conducted quarterly reviews with vendors to develop strong working relationships and assess status of account and products provided. • Recruited to Staff Accountant position in March 2000. Processed invoices for Accounts Payable, performed account reconciliation, and worked with suppliers to resolve billing errors. Show less