Quality Control Technician

Key Responsibilities

• Perform in-process component testing and final release testing for Lateral Flow, ELISA, and Molecular products.
• Review batch records and maintain strict adherence to Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP).
• Calibrate, clean, and maintain laboratory equipment (e.g., pH meters, pipettes).
• Identify and assist in systematic technical and quality troubleshooting.
• Undertake new laboratory procedures, observe proper safety precautions, and support general Quality Management System (QMS) activities.
• Use required sanitization and cleaning protocols (including bleach solutions) while maintaining standard lab safety protocols.

Qualifications & Requirements

• Minimum: Associate degree in Biology, Chemistry, Life Sciences, or a related technical field (or equivalent combination of education and experience) with 1+ years of laboratory and/or quality control experience.
• Preferred: Bachelor's degree in a scientific/technical discipline with 1+ years in a Quality Assurance or Quality Control role within the medical device industry.
• Preferred Background: 2+ years of experience in a regulated industry (GMP, FDA, ISO, USDA).
• Hands-on experience with pipetting, pH meters, and ELISA assays.
• Familiarity with immunochromatographic and enzyme assays, inspection/measurement systems, and data analysis.

Core Competencies & Skills

• Technical Aptitude: Ability to perform standard technical procedures, utilize laboratory equipment, and recognize deviations from approved documented processes.
• Computer Proficiency: Practical knowledge of Database software, Internet applications, MRP/Inventory Management software, and Microsoft Office (Word, Excel, Outlook).
• Mathematical Ability: Competency in applying concepts such as fractions, percentages, ratios, and proportions to lab calculations and data collection.
• Communication & Detail: Strong attention to detail; ability to read/interpret standard operating procedures (SOPs), safety guidelines, and write routine reports.

Physical Demands & Work Environment

• Regularly required to stand and sit; occasionally required to walk.
• Must be capable of handling standard laboratory cleaning protocols (including bleach).
• Standard laboratory setting with a quiet to moderate noise level.