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Quality Control Technician
3 months ago
Job Title: Quality Control Technician II
Location: Scarborough, Maine
Shift: 8 am-5 pm
Duration: 3+ Months
In this role you will perform the 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 USDA. The focus areas for a Quality Control Technician II include but are not limited to: in-process and final release testing, manufacturing batch record review and approval and data analysis. This job description will be reviewed periodically and is subject to change by management.
Responsibilities:
Perform in-process testing for all product components
Perform final kit release testing for all products
Perform product stability testing
Maintain QC laboratory equipment
Calibrate appropriate QC laboratory equipment according to schedule
Review and approve batch records for next stage(s) of manufacturing
Write/review Standard Operating Procedures as necessary
Assist Manager with QC Tracking and Trending Data Program
Assist Manager in troubleshooting and other projects as necessary
Provide support for technical and quality issues as needed
Basic qualifications | education:
Bachelors degree in a Biology, Chemistry, Life Sciences, or other related technical field or the equivalent combination of education and experience.
2+ years' of laboratory and/or quality control experience
Preferred qualifications:
3+ years' experience in a regulated industry.
3+ years' experience with GMP, FDA, ISO and USDA regulations
Competencies:
Knowledge of enzyme and/or immunochromatographic assays, generation of laboratory statistics, performance troubleshooting and data analysis
Working knowledge of Internet software; Fourth Shift and MRP
Inventory/manufacturing software; moderate knowledge of Excel and Microsoft Word
