Quality Control Technician
Select Source International · Scarborough, ME · 3 mo ago
On-siteFull-time
Responsibilities
- Perform testing of in-process components for Lateral Flow, ELISA and Molecular products
- Perform final release testing for Lateral Flow, ELISA and Molecular products
- Troubleshoot of technical and quality issues
- Undertake new procedures and observe proper safety precautions
- Able to perform technical procedures and use laboratory equipment
- Review batch records
- Calibrate/maintain laboratory equipment
- Maintain Good Manufacturing/Laboratory Practices (GMP/GLP)
Requirements
- Basic qualifications | education: Associates degree in Biology, Chemistry, Life Sciences or other related technical field or equivalent combination of education and experience
- 1+ years of laboratory and/or quality control experience
Qualifications
- Preferred Qualifications: 2+ years experience in a regulated industry, 2+ years experience with GMP, FDA, ISO and USDA regulations, Prior experience in the following areas: Pipette experience, pH meter, ELISA assays
Competencies
- Working knowledge of internet sotware, MRP Inventory/Manufacturing software and Microsoft Office Suite (Outlook, Excel, and Word)
- Knowledge of enzyme and/or immunochromatographic assays, inspection/measurement systems, systematic troubleshooting, statistics and data analysis
- Perform a wide variety of activities to support the Quality Management System
Qualifications
- To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.
- The requirements listed below are representative of the knowledge, skill, and/or ability required.
- Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Education And/or Experience
- At least one year in quality assurance role in medical device industry is preferred.
- Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals.
- Ability to write routine reports and correspondence.
- Ability to speak effectively before small groups of customers or employees of organization.