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Quality Control Technician

KYYBA, Inc

Scarborough, ME

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JOB DETAILS
SKILLS
Assays, Biology, Business Development, Business Services, Chemistry, Data Analysis, Database Management Software/Systems (DBMS), Detail Oriented, English Language, Equipment Maintenance/Repair, FDA (Food and Drug Administration), GLP (Good Laboratory Practices), GMP (Good Manufacturing Practices), ISO (International Organization for Standardization), Identify Issues, Infectious Diseases, Information Technology & Information Systems, Internet Application, Laboratory Equipment, Legal, Manufacturing Software, Manufacturing/Industrial Processes, Mathematics, Medical Equipment, Microsoft Excel, Microsoft Office, Microsoft Outlook, Microsoft Word, Physical Demands, Quality Assurance, Quality Control, Quality Management, Regulations, Reporting Skills, Spreadsheets, Statistics, Technical Recruiting, Testing, United States Department of Agriculture (USDA), Word Processing, Writing Skills
LOCATION
Scarborough, ME
POSTED
2 days ago
Job Title: Quality Control Technician
 
About Kyyba:
Founded in 1998 and headquartered in Farmington Hills, MI, Kyyba has a global presence delivering high-quality resources and top-notch recruiting services, enabling businesses to effectively respond to organizational changes and technological advances.
At Kyyba, the overall well-being of our employees and their families is important to us. We are proud of our work culture which embodies our core values; incorporating value, passion, excellence, empowerment, and happiness, creates a vibrant and productive atmosphere. We empower our employees with the resources, incentives, and flexibility that they need to support a healthy, balanced, and fulfilling career by providing many valuable benefits and a balanced compensation structure combined with career development. 
 
Job Description
 
The position of Quality Control Technician is within ***'s 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.
 
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)
 
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 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:
Pipette experience
pH meter
ELISA assays
 
COMPETENCIES:
  • Working knowledge of internet sotware, 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.
  • Supervisory Responsibilities This job has no supervisory responsibilities.
 
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
  • 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.
 
Location: (Scarborough,ME)
 
Disclaimer: 
Kyyba is an Equal Opportunity Employer.
Kyyba does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, ag e, non-disqualifying physical or mental disability, national origin, veteran status or any other basis covered by appropriate law. Minorities / Females / Protected Veterans / Individuals with Disabilities are encouraged to apply. All employment is decided on the basis of qualifications, merit, and business need.”
It is the policy of Kyyba to provide reasonable accommodation when requested by a qualified applicant or employee with a disability, unless such accommodation would cause an undue hardship. The policy regarding requests for reasonable accommodation applies to all aspects of employment, including the application process. If reasonable accommodation is needed, please contact Kyyba at 248-813-9665

Rewards:
Medical, dental, vision
401k 
Term life
Voluntary life and disability insurance
Optional Pre-paid legal plan
Optional Identity theft plan
Optional Medical and dependent FSA
Work-visa sponsorship
Opportunity for advancement
Long-term assignment with opportunity for hire by client 
 
SELECT AWARDS
  • An INC 5000 company for 10 years
  • Corp! Michigan Economic Bright Spots 
  • Crain’s Detroit Business Top Staffing Service Companies in Detroit
  • TechServe Alliance Excellence Award- IT and Engineering Staffing & Solutions
  • Best of MichBusiness winner in HR Wizards & Partnerships
  • Metro Detroit Elite Category: Recruitment, Selection & Orientation for 101 Best & Brightest
  • 101 Best & Brightest Companies to Work for in Michigan
 
 
 
 
 
 

About the Company

K

KYYBA, Inc

Kyyba group of companies are privately held and specialize in staff augmentation, application software and project solutions. In operation for more than 15 years, we have earned an enviable track record and reputation within all the industries we serve. Our unique processes and maturity enables us to understand the needs of the business organizations and provide business solutions that match the real and compelling needs of our customers.

Headquartered in Michigan, Kyyba has multiple office locations and we serve local, regional and national client base consisting of Fortune 500 and middle market companies. Kyyba extends the above solutions and services to a broad spectrum of industry verticals ranging from automotive, insurance, technology, financial, transportation, government and so on.

COMPANY SIZE
100 to 499 employees
INDUSTRY
Staffing/Employment Agencies
FOUNDED
1998
WEBSITE
http://www.kyyba.com/

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