We are seeking a detail-oriented Quality Control Technician to join Abbott's Infectious Disease Developed Markets business unit in Scarborough, Maine. The Quality Control
Technician will perform laboratory testing, product inspections, and quality control activities to ensure products meet company quality standards and regulatory requirements, including FDA, ISO, and CMDR guidelines.
The ideal candidate will have laboratory or quality control experience, knowledge of GMP/GLP practices, and hands-on experience with laboratory equipment and testing procedures.
Key Responsibilities:Perform testing of in-process components for Lateral Flow, ELISA, and Molecular products.
Conduct final product release testing to ensure products meet established quality standards.
Troubleshoot technical issues, testing failures, and quality-related problems.
Perform laboratory testing procedures using appropriate equipment and instruments.
Review and verify batch records, test results, and quality documentation.
Calibrate, operate, and maintain laboratory equipment.
Follow Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP).
Maintain accurate laboratory records and document testing results according to established procedures.
Follow FDA, ISO, CMDR, and other applicable regulatory requirements.
Identify deviations from approved manufacturing procedures and report quality concerns.
Support Quality Management System (QMS) activities and continuous improvement initiatives.
Maintain laboratory cleanliness and follow safety procedures, including the use of bleach for cleaning purposes.
Follow technical procedures, safety guidelines, and standard operating procedures (SOPs).
Associate degree in Biology, Chemistry, Life Sciences, or a related technical field, or an equivalent combination of education and experience.
Minimum 1+ year of laboratory and/or quality control experience.
Knowledge of laboratory testing procedures and equipment.
Ability to follow GMP and GLP guidelines.
Strong documentation, analytical, and troubleshooting skills.
Ability to accurately record and interpret laboratory test results.
Basic computer skills, including Microsoft Word, Excel, and Outlook.
Strong attention to detail and ability to follow established procedures.
Bachelor's degree in a scientific or technical discipline.
2+ years of experience in a regulated industry.
2+ years of experience working with GMP, FDA, ISO, or USDA regulations.
Previous Quality Assurance or Quality Control experience in the medical device industry.
Hands-on experience with:
Pipettes and laboratory testing equipment
pH meters
ELISA assays
Lateral Flow testing
Molecular testing
Enzyme and immunochromatographic assays
Knowledge of inspection and measurement systems, statistical analysis, and systematic troubleshooting.
Experience with MRP, inventory management, or manufacturing software.
Benefits:
Employees hired into these positions are eligible for the following benefits, subject to applicable plan terms and eligibility requirements.
Health Insurance: Medical, dental, and vision insurance options are available through a third-party provider. Employees are responsible for paying the full cost of their insurance premiums.
Retirement Benefits: A 401(k) retirement savings plan is available. No employer matching or other employer contributions are provided.
Paid Time Off (PTO): No PTO is provided other than that required by applicable state and local laws.
| Location | Scarborough, ME |
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