Onsite Clinical Trials QA Lead – Compliance & Audits

Laulima Government Solutions, LLC; Silver Spring (MD); On-site; USD 129,000 - 133,000; Full time

Benefits offered by this job

401K with company match

Medical and dental insurance

Tuition reimbursement

Paid time off

11 paid holidays

Job summary

Alaka`ina Foundation Family of Companies is seeking a Quality Assurance Officer to support an onsite government program in Silver Spring, MD. You will oversee all QA activities for clinical trials, conduct audits, and ensure regulatory compliance with ICH/GCP standards.

Responsibilities include developing SOPs, training staff, and coordinating with the Clinical Trials Center. A Bachelor's degree is preferred; 4+ years in QA for clinical trials is required, with ASQ certification preferred.

Qualifications

• Must have an Associate's degree and at least 4+ years of experience in QA for clinical trials.
• Bachelor's degree preferred and ASQ certification preferred.
• Experience with ICH/GCP regulations and regulatory compliance.

Responsibilities

• Oversee onsite QA for all clinical trial activities.
• Conduct audits and reviews of data and documentation, including laboratory.
• Develop and maintain SOPs, ensure training and compliance of staff.
• Facilitate QA monitoring by study sponsors and coordinate with the CTC.
• Prepare monthly status reports and may lead a team.

Skills

Quality assurance

Clinical trials

Regulatory compliance

Audits

Education

Associate's degree

Bachelor's degree preferred

ASQ certification preferred

Tools

SOP development

ICH/GCP knowledge

Job description

Alaka`ina Foundation Family of Companies is seeking a Quality Assurance Officer to support an onsite government program in Silver Spring, MD. You will oversee all QA activities for clinical trials, conduct audits, and ensure regulatory compliance with ICH/GCP standards.

Responsibilities include developing SOPs, training staff, and coordinating with the Clinical Trials Center. A Bachelor's degree is preferred; 4+ years in QA for clinical trials is required, with ASQ certification preferred.