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

The candidate shall provide Quality Review (QR) Specialist support, to include 100% reviews of data, spreadsheets, tables, listings, figures, etc., as well as SEND packages IAW USAMRIID SOPs as assigned. Some data, spreadsheets, tables, listings, figures and SEND packages may be reviewed using a representative sample approach IAW USAMRIID SOPs. Up to fifteen (15) projects of varying scope per year are included in the workload.

DESCRIPTION OF RESPONSIBILITIES:

• Work with Chief, RRA, 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, SEND packages and records to assure that calculations, content, reference, etc. are technically correct, verifiable, and complete. This review is typically a documented verification of the raw data, spreadsheets, and documents, as well as leveraging a representative sample approach IAW published instructions and USAMRIID SOPs.
• Generate, route, and file a list of major findings for each quality review conducted IAW SOP requirements. Shall flag minor findings/errors within the raw data or electronically, as requested. (Up to 30 QR Major Findings lists generated per year)
• Perform quality review of GLP study final reports and other high visibility reports to assure that calculations, content, references, etc. are technically correct and complete for submission for QA audit. This review is typically a documented verification of study report text, tables, listings and figures with the raw data, spreadsheets, and documents IAW published instructions and USAMRIID SOPs.
• Represent RRA in study and project team meetings, coordinating activities with study directors, principal investigators, and study personnel. Attend study meetings as directed to facilitate planning, coordination, and communication between technical and quality personnel.
• May participate in sponsor and regulatory inspections, as needed.
• Apply scientific knowledge and regulatory expertise in executing assignments and assisting other supported teams.
• Remain abreast of current FDA regulatory requirements, guidance, and current thinking to enhance the expertise and awareness of RRA staff. With input from Chief, RRA, the contractor shall conduct internal training to ensure USAMRIID staff and study team personnel are appropriately trained for their respective job functions.
• 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 or requirements, FDA regulatory expectations and industry standards. (Authoring and or revising department documents is up to 10 per year)
• Attend one to two (1-2) conferences annually to obtain continuing education and to ensure cutting-edge knowledge and techniques are maintained.
• Provide training to USAMRIID personnel and contractors on regulatory topics, including training co-workers in RRA tasks and matters of regulatory interest at USAMRIID.
• Maintain, update, and manage supporting systems, processes and documents that underpin and facilitate the QR 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 the scientific community to communicate and coordinate data package receipt, quality review reports, findings, and corrective actions.
• Categorize, analyze, and report metrics that FileMaker Pro time tracker database collects regarding quality review specialist workload.
• Act as POC for communication issues (e.g., layout changes) between time tracker administration and Quality Review specialists.
• Perform analysis on the collected timelines for tasks and projects to determine standard metrics, which are used by PIs to predict timelines and funding needs more accurately.
• SME with actionable expertise in not only specific scientific and GLP regulatory subject matter, but also with broad hands-on knowledge of USAMRIID processes, procedures and mission, shall:
  • Devise USAMRIID Quality Review's approach to new electronic data management tools, new capabilities, and complex challenges.
  • Act as reviewer on Quality Review department and other RRA documents as assigned.
  • Represent Quality Review in selected high-level meetings where futuristic, outward looking approach and processes regarding USAMRIID's GLP regulatory mission is discussed.
  • As directed by the government, perform troubleshooting to ascertain compliance gaps and process improvement to facilitate greater regulatory adherence.
  • Brief RRA as directed on matters of scientific and regulatory interest.
• Act as POC trainer for new Quality Review Specialists, and for training other Quality Review Specialists on systems, processes, and other topics of interest as assigned.
• Devise improvements to established procedures to increase efficiencies and USAMRIID's adherence to FDA GLP requirements, FDA regulatory expectations, DoD, CDC, and industry standards. The process improvement for new and/or established procedures may require entry into BSL-2 environments for observations only.
• Maintain a current GLP training file, to include summary of training and experience IAW USAMRIID SOPs.
• Other duties as assigned by Supervisor.

REQUIRED DEGREE/EDUCATION/CERTIFICATION:

BS+ two to three (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)

REQUIRED CITIZENSHIP AND CLEARANCE:

• Must be a U.S. Citizen.
• Active Top Secret Clearance

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 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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