Labcorp is looking for a Validations and Reagent Research Associate to join their team in Burlington, NC. In this role you will develop new products and improve existing products following Design Control and Good Manufacturing Practices (GMP).
Essential Duties and 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. Research Associates are expected to be able to organize design projects.
- Plan schedule of research according to company’s timetable and establishes daily and weekly routines necessary to meet project timetable. This includes maintaining regular and consistent attendance as well as making experimental arrangements when unexpected absences occur. Research Associates are expected to be able to manage design projects, making sure critical path delays are identified so they can be resolved.
- 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. Prepare and support submissions to regulatory agencies as assigned.
- 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.
- Adhere to GLP, GMP, ISO 13485 and any other regulatory requirements applicable to current project. This includes but not limited to 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.
- 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. Presentation should be organized to facilitate transfer of important facts. Presentation should also be appropriate for audience.
- Other job duties maybe assigned as needed.
Education and/or Experience:
- Bachelor’s degree from college or university program in Biological or Chemical Science; and greater than two years related experience and/or training; or equivalent combination of education and experience.
Benefits: Employees regularly scheduled to work 20 or more hours per week are eligible for comprehensive benefits including: Medical, Dental, Vision, Life, STD/LTD, 401(k), Paid Time Off (PTO) or Flexible Time Off (FTO), Tuition Reimbursement and Employee Stock Purchase Plan. Casual, PRN & Part Time employees regularly scheduled to work less than 20 hours are eligible to participate in the 401(k) Plan only. For more detailed information, please click here.
Labcorp is proud to be an Equal Opportunity Employer:
Labcorp strives for inclusion and belonging in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications and merit of the individual. Qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex (including pregnancy, childbirth, or related medical conditions), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. Additionally, all qualified applicants with arrest or conviction records will be considered for employment in accordance with applicable law.
We encourage all to apply
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