Quality Control Technician

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 View phone number on click.appcast.io

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