Quality Control Technician
2 weeks ago
Below are the complete Job details for your review :
Title:
Quality Control Technician
Location:
Westbrook, ME 04092 (100% On-Site)
Contract:
12 months of contract to start with possible extension
Summary:
• The position of Quality Control Technician II is within our Infectious Disease Developed Markets business unit located at Scarborough, Maine.
• 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:
• Bachelor's 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 software.
Company DescriptionSelect Source International (SSI) is an IT, Health Care, and Engineering Services consulting firm that has been in business since 1998. SSI consultants have provided exceptional services that have been appreciated by clients, customers, and users alike at several large Fortune 500 companies, mid-size enterprises, and consulting companies.Company DescriptionSelect Source International (SSI) is an IT, Health Care, and Engineering Services consulting firm that has been in business since 1998. SSI consultants have provided exceptional services that have been appreciated by clients, customers, and users alike at several large Fortune 500 companies, mid-size enterprises, and consulting companies.
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