Laboratory Technician

The Quality Control Technician I is responsible for ensuring that the quality of Company products meets the standards set forth by the Company Quality System and regulatory agencies such as the FDA, ISO, and CMDR. This role involves performing various testing procedures, troubleshooting technical and quality issues, and maintaining laboratory equipment in adherence to Good Manufacturing/Laboratory Practices (GMP/GLP).

Key Responsibilities:

• Conduct testing of in-process components for Lateral Flow, ELISA, and Molecular products.
• Perform final release testing for Lateral Flow, ELISA, and Molecular products.
• Troubleshoot technical and quality issues.
• Implement new procedures and adhere to safety precautions.
• Execute technical procedures using laboratory equipment.
• Review batch records for accuracy and compliance.
• Calibrate and maintain laboratory equipment.
• Ensure compliance with GMP/GLP standards.

Basic Qualifications:

• Associate's degree in Biology, Chemistry, Life Sciences, or a related technical field, or an equivalent combination of education and experience.
• 1+ years of laboratory and/or quality control experience.

Preferred Qualifications:

• 2+ years of experience in a regulated industry.
• 2+ years of experience with GMP, FDA, ISO, and USDA regulations.
• Proficiency in the following areas:
• Pipetting techniques
• Use of pH meters
• Conducting ELISA assays

Competencies:

• Working knowledge of internet software, MRP Inventory/Manufacturing software, and Microsoft Office Suite (Outlook, Excel, Word).
• Understanding of enzyme and/or immunochromatographic assays, inspection/measurement systems, systematic troubleshooting, statistics, and data analysis.