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Qc technician/ Quality control/ Lab Technician

Intellectt INC

  • S Portland, ME
  • 7 days ago
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    Skills

    • Assaysunmatched
    • Biologyunmatched
    • Biotech and Pharmaceuticalunmatched
    • Chemistryunmatched
    • Cleanroomunmatched
    • Communication Skillsunmatched
    • Data Analysisunmatched
    • Detail Orientedunmatched
    • Documentationunmatched
    • Equipment Maintenance/Repairunmatched
    • FDA (Food and Drug Administration)unmatched
    • GLP (Good Laboratory Practices)unmatched
    • GMP (Good Manufacturing Practices)unmatched
    • ISO (International Organization for Standardization)unmatched
    • Identify Issuesunmatched
    • Laboratory Equipmentunmatched
    • Laboratory Managementunmatched
    • Laboratory Techniquesunmatched
    • Laboratory Testingunmatched
    • Manufacturingunmatched
    • Mathematicsunmatched
    • Medical Diagnosisunmatched
    • Medical Equipmentunmatched
    • Medical Productsunmatched
    • Presentation/Verbal Skillsunmatched
    • Procedure Developmentunmatched
    • Product Positioningunmatched
    • Product Testingunmatched
    • Quality Assuranceunmatched
    • Quality Controlunmatched
    • Quality Managementunmatched
    • Quality Metricsunmatched
    • Regulationsunmatched
    • Regulatory Requirementsunmatched
    • Root Cause Analysisunmatched
    • Safety Trainingunmatched
    • Standard Operating Procedures (SOP)unmatched
    • Statisticsunmatched
    • Testingunmatched
    • United States Department of Agriculture (USDA)unmatched
    • Writing Skillsunmatched

    Description

    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

    Numbers & Facts

    LocationS Portland, ME

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