Lab Technician

Job Summary

The Lab Technician will support the production and testing of reagents used in In Vitro Diagnostic (IVD) assays. The role involves preparing laboratory solutions and buffers, performing routine testing, conducting validation and stability studies, and maintaining laboratory equipment and inventory.

The candidate must follow laboratory safety procedures and regulatory standards such as ISO 13485, GMP, and GLP.

Key Responsibilities

• Prepare and test reagents used in IVD manufacturing.

• Prepare laboratory buffers, solutions, dilutions, and concentrations.

• Perform validation and stability studies.

• Execute validation protocols and prepare reports.

• Identify, document, and investigate deviations and non-conformities.

• Support root cause analysis and CAPA activities.

• Analyze laboratory data and prepare control charts.

• Create and update SOPs and laboratory documentation.

• Maintain, calibrate, and validate laboratory equipment.

• Maintain laboratory cleanliness, glassware, supplies, and sample inventory.

• Follow ISO 13485, GMP, GLP, and laboratory safety requirements.

• Collaborate with cross-functional teams.

Required Qualifications

• Bachelor's degree in Biology, Biochemistry, Microbiology, Cell Biology, Molecular Biology, or a related scientific field.

• Alternatively, an Associate degree in a related technical field with 4 years of relevant experience.

• Knowledge of scientific laboratory practices and protocols.

• Experience preparing buffers, solutions, dilutions, and molar concentrations.

• Ability to follow protocols and perform experiments with appropriate controls.

Preferred Qualifications

• Experience working in a GMP or GLP laboratory.

• Hands-on experience with micropipettes.

• Experience with immunoassays.

• Knowledge of ISO 13485 and FDA Quality System Regulation (QSR).

• Experience with validation, stability testing, and laboratory documentation.