Quality Assurance Officer

Location MD - Silver Spring

Job Code 12399

# of openings 1

Apply Now (https://phg.tbe.taleo.net/phg04/ats/careers/v2/applyRequisition?org=AKIMEKATECH&cws=43&rid=12399)

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

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.

  REQUIRED DEGREE/EDUCATION/CERTIFICATION:

• Must have a Associates degree and four plus (4+) years of experience.

• Bachelor's degree is preferred.

  REQUIRED CITIZENSHIP AND CLEARANCE:

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

• Must be a US 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. We are proud to state that we do not discriminate in employment decisions on the basis of race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status. If you are a person with a disability and you need an accommodation during the application process, please click here (HRdept@alakaina.com?subject=Request%20for%20accommodation.) to request accommodation. We E-Verify all employees.

  The Alakaina 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 Keaki Technologies, Laulima Government Solutions, Kūpono Government Services, and Kāpili Services, Pookela Solutions, Kīkaha Solutions, LLC, and Pololei Solutions, LLC. Alakaina 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)

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