Qc Technician/ Quality Control/ Lab Technician

Quality Control Technician I Location: South Portland, ME Schedule: Monday Friday | Day Shift Job Summary: We are seeking a detail-oriented Quality Control Technician I to support quality control and laboratory testing activities for medical diagnostic products. This position is responsible for in-process and final release testing while ensuring products meet company quality standards and applicable FDA, ISO, CMDR, GMP, and GLP requirements. Key Responsibilities

• Perform in-process testing of components for Lateral Flow, ELISA, and Molecular products.
• Perform final release testing for finished Lateral Flow, ELISA, and Molecular products.
• Troubleshoot technical and quality issues and assist with root cause investigations.
• Perform laboratory procedures accurately while following established SOPs and safety requirements.
• Operate and maintain laboratory equipment and instruments.
• Calibrate laboratory equipment as required.
• Review batch records and manufacturing documentation for accuracy and completeness.
• Accurately document laboratory test results and quality control activities.
• Follow Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP).
• Support Quality Management System (QMS) activities and continuous quality improvement initiatives.
• Recognize deviations from approved procedures and communicate quality issues appropriately.
• Perform routine laboratory cleaning activities, including the safe use of bleach.
• Follow applicable FDA, ISO, USDA, CMDR, and company regulatory requirements.
• Use laboratory, inventory, database, spreadsheet, and word-processing software as required.

Required Qualifications

• Associate's degree in Biology, Chemistry, Life Sciences, or a related technical field, or equivalent combination of education and experience.
• 1+ year of laboratory and/or quality control experience.
• Ability to follow written procedures and accurately document test results.
• Strong attention to detail and ability to recognize deviations from established procedures.
• Ability to perform basic mathematical calculations involving fractions, percentages, ratios, and proportions.
• Strong written and verbal communication skills.
• Ability to work effectively both independently and as part of a team.

Preferred Qualifications:

• Bachelor's degree in a scientific or technical discipline.
• 2+ years of experience in a regulated industry, preferably medical device, diagnostics, pharmaceutical, or biotechnology.
• Experience working with GMP, GLP, FDA, ISO, or USDA regulations.
• Experience with:
  • Pipetting
  • pH meters
  • ELISA assays
  • Enzyme assays
  • Immunochromatographic assays
  • Laboratory inspection and measurement systems
  • Technical troubleshooting
  • Statistics and data analysis