Quality Control Technician - ELISA
Location: Scarborough, ME
Onsite Flexibility: Onsite
Contract Details
- Position Type: Contract
- Contract Duration: 4 months
- Pay Rate: $28.06 / Hour (USD)
- Work Authorization: Applicants must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.
Job Summary
The Quality Control Technician position is in the client's Infectious Disease Developed Markets business unit 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.
Key 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
- Able to perform technical procedures and use laboratory equipment
- Review batch records
- Calibrate/maintain laboratory equipment
- Maintain Good Manufacturing/Laboratory Practices (GMP/GLP)
Required Skills
- 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
- Perform a wide variety of activities to support the Quality Management System
- Ability to follow Good Manufacturing/Laboratory Practices (GMP and GLP)
- 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 the organization
- Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations
- Knowledge of database software, internet software, inventory software, spreadsheet software, and word processing software
- Ability to follow procedures and accurately document results
- Understanding the manufacturing processes of company products and ability to recognize deviations from approved documented procedures
- Attention to detail
- Ability to use bleach for cleaning purposes is required
Preferred Skills
- 2 years' experience in a regulated industry
- 2 years' experience with GMP, FDA, ISO, and USDA regulations
- Pipette experience
- pH meter experience
- ELISA assay experience
- MLS or MLT credentials
- Experience with biologicals
- Quality control experience
Education Requirements
- Associate's degree in Biology, Chemistry, Life Sciences, or other related technical field, or equivalent combination of education and experience
- Bachelor's degree in a scientific or technical area or equivalent combination of experience and education preferred
Required Experience
- 1 year of laboratory and/or quality control experience
- At least one year in a quality assurance role in the medical device industry is preferred
Nice-to-Have Experience
- 2 years' experience in a regulated industry
- 2 years' experience with GMP, FDA, ISO, and USDA regulations
- Prior experience with pipettes, pH meters, and ELISA assays
Work Environment / Physical Requirements
- While performing the duties of this job, the employee is regularly required to sit and stand; the employee is occasionally required to walk
- The noise level in the work environment is quiet to moderate
- Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions
Benefits
- Medical, Vision, and Dental Insurance Plans
- 401k Retirement Fund
About the Client
This client is a leading healthcare innovator dedicated to improving lives worldwide through a diverse portfolio of medical devices, diagnostics, and nutrition products, with a presence spanning more than 160 countries. The organization's portfolio encompasses cardiovascular care, diabetes management, diagnostic testing, nutritional science, and neuromodulation — with recognized brands that millions of patients rely on every day. Teams here include biomedical engineers, clinical scientists, regulatory affairs specialists, quality control technicians, and commercial operations professionals collaborating across a global network of research, manufacturing, and commercial sites.
About GTT
GTT is an NMSDC-certified Minority Business Enterprise (MBE) headquartered in Portsmouth, New Hampshire. GTT is a subsidiary of Chenega Corporation, an Alaska-based company and one of the largest Alaska Native-owned corporations. An Inc. 5000 honoree and one of SIA's Best Staffing Firms to Work For, GTT connects professionals with Fortune 500 organizations across IT, engineering, construction, utilities, life sciences, financial services, and healthcare throughout the U.S. and Canada. We're committed to diverse, inclusive workplaces and to placing people in roles where they can do their best work.
Job Number: 26-18644 Industry: Manufacturing & Operations
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