Description:
- Responsible for qualification of product(s) in a lab setting following standard operating procedures.
- Will utilize basic laboratory techniques, calculations, materials measurement, operation of laboratory equipment and record keeping necessary to manufacture products.
- Will perform radioactive assays and analysis, TR-FRET assays, fluorescence based assays, and protein concentration assays.
- Responsible for Batch Data Records, notebooks, customer reports and work order documents.
- Utilize specialized technical knowledge and skills to make detailed observations and analyze data to ensure within operating parameters.
- Advise manager of factors that may affect quality of product. Suggest options/ideas for corrective actions.
- Maintain equipment, product inventories and related records as assigned. Note variances on manufacturing documents; audit and evaluate process documents and propose revisions.
- Complete, distribute and file records as required in accordance with Document Control Practices. Identify potential issues in the qualification process; report findings to team management and members for resolution or participate in troubleshooting.
- May lead process improvement projects
- Complete, distribute and file records; prepare ad hoc reports as requested.
- May perform other related duties as required and/or assigned.
- Advise the team lead/manager of factors that may affect quality of the product, initiate problem reports for deviations and non-conforming materials, and suggest options and ideas for corrective actions and preventive actions (CAPA).