Role: Quality Control Technician
Location: Scarborough, ME - 04074
Duration: 5 Months
Shift Timings: (2nd shift) 3pm-11:30pm
Position Summary
The Quality Control Technician position is within our Infectious Disease
Developed Markets business unit located in Scarborough, Maine. In this role,
you will perform work required to ensure Company product quality is maintained
at standards set forth by the Company Quality System and mandated by regulatory
agencies such as the FDA, ISO, and CMDR. This job description will be reviewed
periodically and is subject to change by management.
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 technical and quality issues.
- Undertake new procedures and observe proper safety precautions.
- Perform technical procedures and use laboratory equipment.
- Review batch records.
- Calibrate/maintain laboratory equipment.
- Maintain Good Manufacturing/Laboratory Practices (GMP/GLP).
Basic Qualifications | Education:
- Associate's degree in Biology, Chemistry, Life Sciences, or a related technical field, or an equivalent combination of education and experience.
- 1+years of laboratory and/or quality control experience.
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 software, 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.