Medical Device Quality Control Associate (JA2025)

Job Title:Quality Control Technician
Location (On-site, Remote, or Hybrid?):Scarborough, ME04074 (onsite)
Contract Duration: Contract until 03/31/2027
Work Hours:Monday - Friday (1st shift) 8am-4:30pm

Description:
The position of Quality Control Technician is withinInfectious 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 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.
• 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.