Quality Control Analyst I - Med Device (Entry-Level)

DivIHN Integration Inc; Saint Paul (MN); On-site; USD 52,000 - 65,000; Full time

Job summary

DivIHN Integration Inc invites applications for a Quality Control Analyst I, onsite at St. Paul, MN. The role covers analytical testing from raw materials to finished products in a medical device environment.

The ideal candidate will perform biological, chemical, and physical analyses, document results, and support environmental monitoring programs while adhering to cGMP, FDA, and SOP requirements. A bachelor’s in chemistry or biology with analytical coursework is preferred.

Qualifications

• Bachelor’s degree in Chemistry or Biological Sciences with Analytical Chemistry coursework.
• Associates and 2-3 years in med device or pharma background will also be considered.
• Knowledge of cGMP manufacturing is advantageous.

Responsibilities

• Conduct biological, chemical, and physical analyses on medical devices through all stages of manufacturing.
• Perform assays requiring analytical skills and understanding of biology and chemistry principles.
• Maintain data integrity and ensure compliance with SOPs, FDA, GLP, QSR, and cGMP regulations; write exception documents.
• Use laboratory instrumentation and computer systems (e.g., LIMS) to record data.
• Perform audits of laboratory and manufacturing processes as required.

Skills

Multitasking

Communication

English proficiency

Computer literacy

Lab techniques

Data integrity

Education

Bachelor’s degree in Chemistry or Biological Sciences with Analytical Chemistry coursework

Associates and 2-3 years in med device/pharma background

Tools

LIMS

Job description

DivIHN Integration Inc invites applications for a Quality Control Analyst I, onsite at St. Paul, MN. The role covers analytical testing from raw materials to finished products in a medical device environment.

The ideal candidate will perform biological, chemical, and physical analyses, document results, and support environmental monitoring programs while adhering to cGMP, FDA, and SOP requirements. A bachelor’s in chemistry or biology with analytical coursework is preferred.