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 contract with USAMRIID 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.

DESCRIPTION OF RESPONSIBILITIES:

• 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.
• 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. Flag minor findings/errors within the raw data or electronically, as requested.
• 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. 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.
• 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.
• 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 RRA tasks and matters of regulatory interest at USAMRIID.
• 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 raw data/data package receipt, findings, and corrective actions, as needed.
• 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

• Must be able to obtain a NACI 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 of individuals with disabilities and veterans. We are proud to state that we do not illegally discriminate in employment decisions on the basis of any protected categories. 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

"EOE, including Disability/Vets" OR "Equal Opportunity Employer, including Disability/Veterans"

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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