Labcorp is looking to develop new products and improve existing products following Design Control and Good Manufacturing Practices (GMP).
Requirements
- Adhere to GLP, GMP, ISO 13485 and any other regulatory requirements applicable to current project.
- Completion of documentation, maintaining proper labeling of reagents and components, proper labeling and storage of raw data, and proper use of PPE required for task.
- Bachelor’s degree from college or university program in Biological or Chemical Science
- Greater than two years related experience and/or training
- Equivalent combination of education and experience
- Knowledge of Design Control and Good Manufacturing Practices (GMP)
- Experience with risk assessments, FMEAs, and regulatory submissions
Responsibilities
- Develop new products and product improvements. Responsible for but not limited to leading discussions regarding design projects, preparation of verification and validation reports, preparation of research plans, designing experiments, outlining research procedures to follow, determining critical steps, conducting assigned experiments, and analyzing data.
- Plan schedule of research according to company’s timetable and establishes daily and weekly routines necessary to meet project timetable.
- Participate in design control and regulatory activities. Serve on project teams and review teams as assigned. Prepare Risk assessments, FMEAs, risk reports, project plans, design inputs, design component specifications, protocols and reports as assigned or required for their projects.
- Analyze data critically, looking for trends and determining when additional testing is needed.
- Able to prepare all components required for production of strip lots, as well as analyze strip performance. Able to formulate a test strip lot and be able to make decisions as to levels to test and decide on an acceptable formulation for a clinical lot.
- Troubleshoot problems with existing tests and tests under development. This includes aiding Formulations, QC, and Production departments with technical issues and participating in root cause analysis of complaints and product development issues.
- Present experimental analysis, experimental data, complaint analysis, new and improved processes to project teams, design review teams, management, and affected departments.
Other
- Bachelor’s degree from college or university program
- Greater than two years related experience and/or training
- Equivalent combination of education and experience
- Regular and consistent attendance
- Ability to manage design projects and make experimental arrangements when unexpected absences occur
- Ability to work in a team environment and participate in cross-functional teams
