Courtney Fulcher Email & Phone Number

Durham, Nc, Us

• Manufacture subassemblies, reagents, and controls under SOP and GMP guidelines for FDA approved medical devices.• Test controls, reagents, and raw materials for performance. • Perform data analysis to properly assign control values, verify reagent productions.• Assemble and package finished goods. Conduct reworks as needed.• Maintain and complete Device History Records, Device Master Records.• Work across departments for In-House studies and projects.• Write and revise Work Instructions, SOPs.• Generate Non Conformances, and implement solutions accordingly.• Maintain inventory through regular auditing and INFOR.

• Prepare various specimen types in accordance with SOP guidelines for DNA extraction and amplification. Including but not limited to Qiagen, Maxwell, and QIAamp DNA Investigatormethods.• Perform extended testing on paternity specimens, engraftments samples, and cell lineauthentication testing.• Read electropherogram results, analyze data and use technical discretion to determineadditional testing required.• Participate in ongoing Quality Control Program to ensure validity of reagents andprocedures.• Regularly evaluate and update SOPs.• Complete and prepare results for CAP proficiency testing.• Work independently and collectively to complete tasks within strict deadlines.• Communicate effectively across departments to ensure appropriate testing is completed in atimely manner.• Responsible for training new employees and maintaining competencies of current employees.