Biodefense Regulated Quality Review Specialist

The Alaka`ina Foundation Family of Companies (FOCs) is looking for a qualified Biodefense Regulated Review Specialist to support our contract with USAMRIID in Frederick, MD.

The candidate shall provide Quality Review (QR) Specialist support to the USAMRIID's Medical Countermeasure (MCM) Advanced Test & Evaluation (T&E) capability, to include 100% data audits and 100% verification of final reports for both well documented and GLP compliant studies.

DESCRIPTION OF RESPONSIBILITIES:

• Work with Chief, QARCO, Study Directors, principal investigators, and other key staff to perform Quality Reviews of documents and records associated with nonclinical studies, to include those conducted under FDA Good Laboratory Practice (GLP) requirements.
• Perform quality review of laboratory study files and records to assure that calculations, content, reference, etc. are technically correct and complete for submission for QA audit.
• Generate, route and file review QR reports for each quality review
• Perform quality review of GLP study final reports and other high visibility final reports to assure that calculations, content, reference, etc. are technically correct and complete for submission for QA audit.
• Coordinate and manage corrective action/ preventive action (CAPA) activities related to QARCO supported studies and processes as directed.
• Represent QARCO in study and project team meetings, coordinating activities with Study Directors, Principal Investigators and study personnel. The candidate shall coordinate with QAU staff on scheduling and quality standards for submissions for QA audit as well as coordinating the scheduling and tracking for all quality review activities.
• Ensure compliance with FDA regulations, e.g., 21CFR314, where the goal is inclusion in FDA animal rule submission in review of records and documents.
• Write and revise department documents, such as SOPs and work instructions; providing peer review of documents. Devise improvements to established procedures to improve workflow and efficiency and/or increase USAMRIID's adherence to FDA GLP requirements, FDA regulatory expectations and Industry Standards.
• Attend 1-2 conferences annually in order to obtain continuing education and to ensure cutting edge knowledge and techniques are maintained.
• Provide training to USAMRIID personnel and candidates on regulatory topics, including training co-workers in QARCO tasks and matters of regulatory interest at USAMRIID.
• Manage, file and archive Quality Review records, to include reports, review documentation, schedules, log records and the like as directed IAW USAMRIID SOPs and published instructions.
• Maintain, update and manage supporting systems, processes and documents that underpin and facilitate the Quality Review Mission, to include maintaining and updating metrics information in an electronic database or other format, to include project information, times, dates and the like as directed.
• Interface directly with scientific community to communicate and coordinate data package receipt, quality review reports, findings and corrective actions.

REQUIRED DEGREE/EDUCATION/CERTIFICATION:

BS+2-3 years' experience

REQUIRED SKILLS AND EXPERIENCE:

• Quality Control/Quality Review in a GLP environment
• FDA Animal Rule experience
• Ability to read, update, and create SOPs
• Experience with incident investigation
• High functioning in a QA audit as contributor and in preparation

DESIRED SKILLS AND EXPERIENCE:

• Previous DoD experience
• Prior experience with assays (i.e.- ELISA and High-Performance Liquid Chromatography (HPLC)

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 to request accommodation. We E-Verify all employees.

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, Kpono Government Services, and Kapili Services, Po`okela Solutions, Kkaha Solutions, LLC, and Pololei Solutions, LLC. Alaka`ina Foundation activities under the 501(c)3 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

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