• Quality Assurance Officer

    Alaka'ina Foundation Family of Companies (Silver Spring, MD)


    Quality Assurance Officer

     

    Location MD - Silver Spring

     

    Job Code 13296

     

    # of openings 1

     

    Alaka`ina Foundation Family of Companies is looking for a Quality Assurance Officer to support our government customer on site in Silver Spring, Maryland.

     

    Responsible for all onsite Clinical Trial activities involving quality assurance and compliance with applicable regulatory requirements; conducts audits and reviews/analyzes data and documentation. Facilitate quality assurance monitoring by study sponsors. Relies on experience and judgment to plan and accomplish goals and tasks. Performs a variety of tasks. May lead and direct the work of others.

    DESCRIPTION OF RESPONSIBILITIES:

    + Responsible for Quality Assurance/Regulatory Compliance of all onsite Clinical Trial activities

    + Conducts audits and reviews/analyzes data and documentation. This includes internal audits such as the laboratory.

    + Develops, maintains, and ensures compliance with Standard Operating Procedures (SOPs), be knowledgeable and compliant with all Human Subjects’ Protection, FDA, and current Good Clinical Practice (GCPs) regulations as well as ensuring all contractor study personnel remain trained and up to date in their respective fields.

    + Facilitates quality assurance monitoring by study sponsors.

    + Relying on experience and judgment to plan and accomplish goals and tasks.

    + Prepares and maintains instructions and pre-established guidelines to perform the functions of the job.

    + Coordinates with entire Clinical Trials Center (CTC) team to ensure compliance for all studies regardless of study phase.

    + Ensures successful completion of all internal and external audits, assists Clinical Research Coordinator (CRC) with regulatory compliance, maintains staff credentials, provides Quality Control of all source documents, conducts chart review, and updates SOPs as necessary.

    + Prepares monthly status report and performs a variety of tasks. May lead/direct the work of others.

    + Other duties as assigned by Supervisor.

    REQUIRED DEGREE/EDUCATION/CERTIFICATION:

    + Must have an Associate's degree and four plus (4+) years of experience.

    + Bachelor's degree is preferred.

    + Minimum of five (5) years of experience in quality assurance for clinical trials, with expertise in ICH/GCP compliance.

    + Certification in quality management (e.g., ASQ or equivalent) is preferred.

    REQUIRED CITIZENSHIP AND CLEARANCE:

    + Must be able to pass a NACI for Common Access Card.

    + Must be a U.S. Citizen.

     

    The Alaka`ina Foundation Family of Companies (FOCs) is a fast-growing government service provider. Employees enjoy competitive salaries; a 401K plan with company match; medical, dental, disability, and life insurance coverage; tuition reimbursement; paid time off; and 11 paid holidays.

     

    We are an Equal Opportunity/Affirmative Action Employer of individuals with disabilities and veterans. We are proud to state that we do not illegally discriminate in employment decisions on the basis of any protected categories. If you are a person with a disability and you need an accommodation during the application process, please click here ([email protected]?subject=Request%20for%20accommodation.) to request accommodation. We E-Verify all employees

     

    •EOE, including Disability/Vets” OR “Equal Opportunity Employer, including Disability/Veterans”

     

    The Alaka`ina Foundation Family of Companies (FOCs) is comprised of industry-recognized government service firms designated as Native Hawaiian Organization (NHO)-owned and 8(a) certified businesses. The Family of Companies (FOCs) includes Ke`aki Technologies, Laulima Government Solutions, Kūpono Government Services, and Kāpili Services, Po`okela Solutions, Kīkaha Solutions, LLC, and Pololei Solutions, LLC. Alaka`ina Foundation activities principally benefit the youth of Hawaii through charitable efforts which includes providing innovative educational programs that combine leadership, science & technology, and environmental stewardship.

     

    For additional information, please visit www.alakainafoundation.com (https://www.alakainafoundation.com/careers)

     

    #ClearanceJobs

    #LI-JS1