Ke`aki Technologies, LLC, headquartered in Honolulu, Hawaii, is a Native Hawaiian Organization (NHO) owned business. A premier government services company, Ke`aki Technologies offers a full spectrum of solutions that improve the performance and operational effectiveness of our government and Department of Defense customers. Our mission synchronized solutions are designed to deliver exactly what our customers need, when they need it. From base and range operations to biomedical defense support to telecommunications and IT services, we deliver the exact talent, tools and technologies needed to meet mission requirements.
Ke`aki Technologies has an exciting opportunity for a Quality Assurance Consultant for a short term project. The position will be located at U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID) at Fort Detrick, Frederick, Maryland supporting the Quality Assurance and Regulatory Compliance Office (QARCO). The position requires a favorable NAC background check, and a signed confidentiality agreement.
- The position requires at least a MS; PHD preferred.
- Required Experience at time of hire: 20 years of experience in industry; 15years of experience auditing clinical data management systems, or recognized preeminence in the field
Focused Task Order for SME Quality Assurance Consultant:
Audit of the USAMRMC Enterprise Information Technology Program Management Office electronic Clinical Data Management System “Inform” for compliance with 21 CFR 11, GLP and GCP Regulations for the US Army Medical Research Institute of Infectious Diseases (USAMRIID)
Audit the EIT PMO’s EDC-CRDMS, “Inform-GTM with Clintrial”, to ascertain the level of compliance in terms of adherence to 21 CFR 11, the ICH and FDA GCP regulations, FDA GLP regulations and to determine the level to which the system meets FDA regulatory expectations and industry standards. All work will be in direct support of USAMRIID. This assignment will involve the following activities:
Perform an audit of Inform-GTM and Clintrial with associated system modules, to include audit of validation package, security, system lifecycle, system administration, backup and restore, business continuity and disaster recovery planning, e-data handing, functionality. All SOPs for the system and for the use of the system will also be audited.
Generate a project plan to define timelines and deliverables, to include at a minimum Audit Agenda and Audit Report to fully describe audit activities and to itemize any findings, observations and proposed corrective actions.
Draft documents will be reviewed by USAMRIID QARCO Personnel. Comments will be provided to the contractor. After incorporating all comments, the final documents will be presented to USAMRIID.
The contractor may train USAMRIID QARCO Auditor(s) who will participate on the audit team. USAMRIID will provide support and coordination with the Points of Contact necessary to facilitate the audit.
FDA 21 CFR Part 50, 54, 56, 312, 314
FDA 21 CFR Part 58
FDA 21 CFR Part 11
ICH GCPs (International Conference on Harmonization Good Clinical Practices)
USAMRIID SOP AD-08-00 “GLP, GCP and ISO Compliance Training Program”
USAMRMC Policy 2006-22 “Validation and Qualification of Equipment used for the FDA-Regulated activities within the Command”
USAMRMC Policy 2008-11 “Development, Implementation and Adherence to Change Management System for FDA-Regulated Activities”
Summary of Requirements
Requirement 1: Prepare a project plan for the audit including timelines, activities and deliverables needed to complete the project. Approval of the project plan is performed by the government.
Requirement 2: Prepare an audit agenda, to include personnel, documentation and system access required. Approval of the audit agenda is performed by the government.
Requirement 3: Perform the audit, and train the QARCO auditors as part of the audit team. The audit will conclude with an outbrief for all those involved in the audit, wherein the auditor discusses the audit, and any comments, findings and recommended corrective actions.
Requirement 4: Prepare an audit report, summarizing all activities of the audit, including dates of the audits, and personnel involved. The audit report will list all findings, and any recommended corrective actions and will be reported to USAMRIID Management. Approval of the audit report is performed by the government.
The contractor is responsible for the stated deliverables, and an audit team may perform the audit and assist in other parts of the execution of the contract.
Detailed project plan with timeline for completing all aspects of the audit including
Submission of the audit agenda
Execution of the audit
Submission of the audit report
Any other activities needed to complete the audit and meet regulatory expectations as approved by government personnel
Government approved audit agenda, to be presented at an initial meeting with relevant MRMC EIT PMO personnel and USAMMDA EDC-CRDMS Product Sponsor to discuss timelines and levels of engagement necessary to accomplish the audit.
Government approved audit report, in Microsoft Word, ready for staffing using.
Training documentation IAW USAMRIID SOP for the trained QARCO auditor(s) who participated on the audit team
JOB TYPE: Part-Time
FLSA STATUS: Non-Exempt
Ke`aki Technologies LLC 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 vacation and sick time; and 10 paid holidays.
For additional information on Ke`aki Technologies, LLC, please visit www.keakitech.com .
Ke`aki Technologies, LLC is proud to be an Equal Opportunity Employer/Affirmative Action Employer (EEO/AA) and applicants will be considered without regard to race, color, religion, age, sex, disability, national origin, marital status, or genetic information.