Biodefense Regulated Quality Review Specialist

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

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.

• Provide Quality Review (QR) Specialist support, to include 100% review of data, spreadsheets, tables, listings, figures, etc., as well as SEND packages and 100% verification of final reports. Some data spreadsheets, tables, listings, figures and SEND packages may be reviewed using a representative sample approach IAW USAMRIID SOPs. The workload shall include the review of all USAMRIID studies (GLP and non- GLP) that are to be submitted to the US FDA for regulatory decision making.
  
  (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, references, etc. are technically correct and complete for submission for QA audit. This review is typically a documented 100% verification of the raw data, spreadsheets, and documents, as well as leveraging a representative sample approach IAW published instructions.
• 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. (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, reference, etc. are technically correct and complete for submission for QA audit. This review is typically a documented 100% verification of study report text, tables, listings and figures with the raw data, spreadsheets, and documents IAW published instructions.
• Represent RRA in study and project team meetings, coordinating activities with study directors, principal investigators, and study personnel. Attend GLP study kick off 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 requirements, FDA regulatory expectations and industry standards. ( 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, at no additional cost to the Government.
• 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 SD/PI and study personnel to communicate and…