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