Global Clinical QA/QC Specialist (Travel Required)

Ke'aki Technologies; Frederick (MD); On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

401K match

Health insurance

Tuition reimbursement

Paid holidays

Paid vacation and sick time

Job summary

Laulima Government Solutions LLC is seeking a QA/QC professional to review international clinical trial sites and assist with clinical sample repository management. The role emphasizes GCLP compliance, QA/QC documentation, and coordination with Human Use and Ethics offices.

The candidate should have a Bachelor’s degree in Project Management or Quality Management, at least three years post-graduate life science QA experience, and strong communication and organizational skills.

Qualifications

• Bachelor's Degree in Project Management or Quality Management or related field.
• Minimum of three years post-graduate experience in a life science/research Quality Control or Quality Assurance clinical laboratory.
• Experience with laboratory practices for international clinical trials.
• Outstanding organizational skills with the ability to multi-task and prioritize.
• Familiarity with pre-analytic, analytic, and post-analytic processes, including both moderate and high complexity testing.
• Ability to build constructive relationships; use diplomacy and tact.

Responsibilities

• Review international clinical trial sites for compliance with FDA and GCLP.
• Assess engagement in External Quality Assurance (EQA) programs.
• Inspect validation and maintenance of clinical laboratory instruments.
• Monitor and improve Quality Management System (QMS) processes.
• Maintain QA/QC documentation and report deviations.
• Coordinate sample repository transfers and barcode labeling.
• Travel internationally about 15% to Uganda and other sites.

Skills

QA/QC in clinical labs

Regulatory compliance

Organizational skills

Communication

Team collaboration

Travel readiness

Education

Bachelor's Degree in Project Management or Quality Management

Clinical Laboratory Management related field

Tools

REDCap

FreezerPro

FreezerWorks

Microsoft Office Suite

Job description

Laulima Government Solutions LLC is seeking a QA/QC professional to review international clinical trial sites and assist with clinical sample repository management. The role emphasizes GCLP compliance, QA/QC documentation, and coordination with Human Use and Ethics offices.

The candidate should have a Bachelor’s degree in Project Management or Quality Management, at least three years post-graduate life science QA experience, and strong communication and organizational skills.