Quality Control Associate, Lab

POSITION SUMMARY The Quality Control Associate is responsible for reviewing clinical trial data and laboratory data to ensure compliance with ICH/GCP guidelines and Standard Operating Procedures (SOPs). The job requires attention to detail, creating and using checklists, noticing small differences and following specific instructions.

KEY RESPONSIBILITIES Review clinical trial data to verify compliance with ICH/GCP and SOP requirements; identify discrepancies and generate queries as needed

Observe and verify compliance related to the administration of investigational products

Communicate identified issues and resolutions with department leadership, study management teams, and laboratory teams

Understand sample collection, handling, and processing for biological samples.

Review study protocols and identify the required tests and tasks for the laboratory.

Review for accuracy and correct the translation of written text into the steps of the laboratory process instructions.

Familiar with sample collection containers and is interested in research to find a container if not known.

Perform laboratory-related activities, including requesting and ordering study-specific laboratory tests

Perform other duties as assigned

Job Type: Full-time Benefits:401(k) matching

Dental insurance

Employee assistance program

Flexible spending account

Health insurance

Health savings account

Paid time off Vision insurance

Work Location:

In person REQUIRED QUALIFICATIONS Bachelor’s degree or significant laboratory experience in a biological science field

PREFERRED QUALIFICATIONS:

Prior experience in clinical research

Prior laboratory experience (Biological samples)
General understanding of laboratory workflows, documentation, and data