Bioanalytical Quality & Lab Operations Specialist

Insight Global

New Haven (CT)

On-site

USD 70,000 - 90,000

Full time

5 days ago

Be an early applicant

Application generator

Get a reply from this employer — a resume and cover letter tailored to exactly what they’re hiring for.

Get past ATS filters

Job summary

Insight Global is seeking a Bioanalyst to support bioanalytical operations in an early-phase clinical trial setting. You will ensure GxP compliance, data integrity, and quality oversight while performing hands-on lab support and documentation review.

You will assist with inventory, asset management, study planning, and reporting, and coordinate laboratory activities with scientists and project teams. Experience with equipment qualification, biospecimen handling, and software validation is

Qualifications

2-4 years of laboratory experience in a regulated (GxP) environment.
Strong understanding of laboratory operations, quality oversight, and data integrity principles.
Excellent analytical, organizational, and time management skills with the ability to manage multiple priorities.
Experience with laboratory documentation, regulatory compliance, equipment qualification, and biospecimen handling.

Responsibilities

Ensure GxP compliance and data integrity across laboratory activities.
Oversee inventory and asset management for lab operations.
Review and maintain laboratory documentation and study plans.
Support study plan and report preparation, ensuring accuracy and timeliness.
Provide quality review of laboratory data and reports to support clinical research outcomes.
Coordinate laboratory activities with scientists and project teams, and assist with biospecimen processing.