Quality Review Specialist

Quality Review Specialist

Location MD - Fort Detrick

Job Code 12352

of openings 1

Apply Now (https : / / phg.tbe.taleo.net / phg04 / ats / careers / v2 / applyRequisition?org=AKIMEKATECH&cws=43&rid=12352)

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

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 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 USAMRIIDs adherence to FDA GLP requirements, FDA regulatory expectations and industry standards.
• 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 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 coordinate raw data / data package receipt, findings, and corrective actions, as needed.
• Devise improvements to established procedures to increase efficiencies and USAMRIIDs 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.
• Other duties as assigned.

REQUIRED DEGREE / EDUCATION / CERTIFICATION :

BS and two to three (2-3) years experience

REQUIRED SKILLS AND EXPERIENCE :

DESIRED SKILLS AND EXPERIENCE :

REQUIRED CITIZENSHIP AND CLEARANCE :

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 (HRdept@alakaina.com) 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, K?pono Government Services, and Kapili Services, Po`okela Solutions, K?kaha Solutions, LLC, and Pololei Solutions, LLC. Alaka`ina Foundation activities 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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