Quality Control Technician

Quality Control TechnicianThis position of Quality Control Technician I is located at South Portland, 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. Responsibilities:Perform testing of in-process components for Lateral Flow, ELISA and Molecular productsPerform final release testing for Lateral Flow, ELISA and Molecular productsTroubleshooting of technical and quality issuesUndertake new procedures and observe proper safety precautionsAble to perform technical procedures and use laboratory equipmentReview batch recordsCalibrate/maintain laboratory equipmentMaintain Good Manufacturing/Laboratory Practices (GMP/GLP)Basic Qualifications | 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 experiencePreferred 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 assaysCompetencies:· 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.Qualifications:· To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.· The requirements listed below are representative of the knowledge, skill, and/or ability required.· Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.· Ability to follow Good Manufacturing/Laboratory Practices (GMP and GLP)Education and/or Experience:· Bachelor's degree in a scientific or technical area or equivalent combination of experience and education. At least one year in quality assurance role in medical device industry is preferred.Language Skills:English Skills:· 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 organization.Mathematical Skills· Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.Computer Skills· To perform this job successfully, an individual should have knowledge of Database software; Internet software; Inventory software; Spreadsheet software and Word Processing software.Certificates, Licenses, Registrations - None Other Skills and Abilities:· 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.Physical Demands:· The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.· While performing the duties of this Job, the employee is regularly required to sit and stand. The employee is occasionally required to walk.Work Environment· The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.· The noise level in the work environment is quiet to moderate.About generis tek: generis tek is a boutique it/professional staffing based in Chicago land. We offer both contingent labor & permanent placement services to several fortune 500 clients nationwide. Our philosophy is based on delivering long-term value and build lasting relationships with our clients, consultants and employees. Our fundamental success lies in understanding our clients' specific needs and working very closely with our consultants to create a right fit for both sides. We aspire to be our client has most trusted business partner.