Quality Assurance Officer

@ Alakaina Family of Companies

Job Overview

The Quality Assurance Officer at Alakaina Family of Companies supports government clients on site in Silver Spring, Maryland. This role involves overseeing clinical trial quality assurance activities, ensuring regulatory compliance, and performing audits and data review.

Responsibilities

• Manage Quality Assurance and Regulatory Compliance for onsite clinical trial activities.
• Conduct audits, reviews, and data/documentation analysis including internal audits.
• Develop, maintain, and ensure compliance with Standard Operating Procedures (SOPs) including compliance with FDA, GCP, and Human Subjects' Protection regulations.
• Facilitate quality assurance monitoring by study sponsors and coordinate with the Clinical Trials Center team.
• Prepare monthly reports, update SOPs, and perform various tasks as assigned.
• May lead and direct the work of other team members.

Qualifications

• Associate's degree required; Bachelor's degree preferred.
• Four or more years of relevant experience.
• MUST pass a NACI for Common Access Card and be a U.S. Citizen.

Benefits & Company Overview

Alakaina Family of Companies is a fast-growing government service provider offering competitive salaries, 401K with match, comprehensive insurance, tuition reimbursement, paid time off, and 11 paid holidays. The company is an Equal Opportunity/Affirmative Action Employer.

Key skills/competency

• Quality Assurance
• Regulatory Compliance
• Clinical Trials
• SOP Development
• Auditing
• Data Analysis
• FDA Regulations
• GCP
• Team Coordination
• Reporting