Job Description
Purpose of the Job and Expected Outcome
The Laboratory Scientist is responsible for development and validation of new methods within the clinical laboratory which may involve various disciplines including, but not limited to ELISA, PCR, Flow Cytometry, HPLC/MS and as well as contributing to multiple projects with little supervision. The Laboratory Scientist will act as a project manager within the laboratory, clearly communicating with management, quality assurance and vendors to ensure on time and accurate deliverables.
Key Accountabilities
- Research literature and sources, develop plans for validations and perform method validations, maintaining appropriate documentation throughout process.
- Assist management in the writing of procedures (SOPs) and training of technical staff on validated methods.
- Perform statistical analysis and generate validation reports per relevant GCP guidelines.
- Contribute to the sales process with timely, competent answers to RFI’s and proposals.
- As needed: perform laboratory testing according to established global protocols, timelines and procedures (SOPs) to generate high-quality, error-free, analytical results. Maintain equipment and perform QC procedures within established guidelines, keeping appropriate documentation.
- Report deviations, perform and document corrective and preventative actions to support QA.
- Assure full laboratory compliance with federal (CLIA, CAP) and state requirements and where needed, maintain GLP compliance (e.g. FDA and OECD GLPs).
- From time to time, perform other lab-related duties as delegated by management, including inventory, archiving and safety tasks, acting as a reliable back-up to colleagues on leave