Scientist

This 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 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.

“Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of – Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans.”

If you are inclined, I would be happy to set up some time to chat more about your background and career interests to see if there could be a possible match. Please feel free to call me on 732-806-7467 or send me email on nirajk@mindlance.com

Regards

Niraj kumar