Quality Control Technician

Intellectt Inc; Scarborough (ME); On-site; USD 42,000 - 64,000; Full time

Job summary

Intellectt Inc. is seeking a Quality Control Technician in Scarborough, ME to perform in-process and final release testing for Lateral Flow, ELISA, and Molecular products.

The role supports QA activities and requires adherence to Quality System and regulatory requirements including FDA, ISO, and CMDR standards. The candidate will document results, calibrate lab equipment, and follow GMP/GLP procedures while maintaining rigorous safety practices and contributing to the QMS.

Qualifications

• Associate Degree in Biology, Chemistry, Life Sciences, or related field, or equivalent combination of education and experience
• 1+ year of laboratory and/or quality control experience
• Ability to follow GMP and GLP procedures
• Ability to accurately document test results and follow established procedures
• Strong attention to detail
• Ability to read and interpret safety rules, operating instructions, maintenance instructions, and procedure manuals
• Ability to write routine reports and correspondence
• Ability to communicate effectively with employees and customers

Responsibilities

• Perform in-process testing of components for Lateral Flow, ELISA, and Molecular products
• Perform final release testing for Lateral Flow, ELISA, and Molecular products
• Troubleshoot technical and quality issues
• Perform technical laboratory procedures using appropriate laboratory equipment
• Follow established procedures and proper safety precautions
• Review batch records for accuracy and completeness
• Calibrate and maintain laboratory equipment
• Maintain GMP/GLP standards and practices
• Support activities related to the Quality Management System (QMS)
• Accurately document laboratory test results and activities
• Recognize deviations from approved manufacturing procedures
• Use bleach for required cleaning activities
• Apply systematic troubleshooting, statistics, and data analysis as needed

Skills

Attention to detail

Documentation

Communication

Reading procedures

Writing reports

Education

Associate degree in Biology, Chemistry, Life Sciences or related field

Tools

Pipette

PH meter

ELISA equipment

Job description

The Quality Control Technician performs testing and laboratory activities to ensure company products meet established Quality System and regulatory requirements, including FDA, ISO, and CMDR standards. The role supports in-process and final release testing for Lateral Flow, ELISA, and Molecular products.

Key Responsibilitie

• sPerform in-process testing of components for Lateral Flow, ELISA, and Molecular products
• .Perform final release testing for Lateral Flow, ELISA, and Molecular products
• .Troubleshoot technical and quality issues
• .Perform technical laboratory procedures using appropriate laboratory equipment
• .Follow established procedures and proper safety precautions
• .Review batch records for accuracy and completeness
• .Calibrate and maintain laboratory equipment
• .Maintain GMP/GLP standards and practices
• .Support activities related to the Quality Management System (QMS
• .Accurately document laboratory test results and activities
• .Recognize deviations from approved manufacturing procedures
• .Use bleach for required cleaning activities
• .Apply systematic troubleshooting, statistics, and data analysis as needed

.
Required Qualificatio

• nsAssociate Degree in Biology, Chemistry, Life Sciences, or another related technical field, or equivalent combination of education and experienc
• e.1+ year of laboratory and/or quality control experienc
• e.Ability to follow GMP and GLP procedure
• s.Ability to accurately document test results and follow established procedure
• s.Strong attention to detai
• l.Ability to read and interpret safety rules, operating instructions, maintenance instructions, and procedure manual
• s.Ability to write routine reports and correspondenc
• e.Ability to communicate effectively with employees and customer

.
Preferred Qualificati

• ons2+ years of experience in a regulated indust
• ry.2+ years of experience with GMP, FDA, ISO, and USDA regulatio
• ns.Experience with pipett
• es.Experience using a pH met
• er.Experience performing ELISA assa
• ys.At least 1 year of quality assurance experience in the medical device industry preferr
• ed.Bachelor's degree in a scientific or technical field preferr