Quality Review Specialist II

Overview

The Alaka`ina Foundation Family of Companies (FOCs) is looking for a Quality Review (QR) Specialist to support our government customer in Frederick, Maryland
.

• 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. Workload:
  Up to 15 projects of varying scope per year
• 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. Contractor shall flag minor findings/errors within the raw data or electronically, as requested. Workload:
  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. Workload:
  Authoring and or revising department documents is up to 10 per year
• Attend 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 ntain, 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 in-house, web-application Quality Review time tracker database collects regarding quality review specialist workload.
• Act as POC for communication issues when Branch Chief is unavailable between the database administrator and Quality Review Specialists. Perform analysis on the collected timelines for tasks and projects to determine standard metrics,…