Quality Control Technician
3 weeks ago
The position of Quality Control Technician is within our Infectious Disease Developed Markets business unit located at Scarborough, Maine. In this role you will perform work required to ensure Company product quality is maintained at standards set forth by 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
· Troubleshooting 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)
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 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: o Pipette experience
COMPETENCIES:
· Working knowledge of internet sotware, MRP Inventory/Manufacturing software and Mircosoft Office Suite (Outlook, Excel, and Word).
· Knowledge of enzyme and/or immunochromatographic assays, inspection/measurement systems, systematic troubleshooting, statistics and data analysis.
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