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Sr. Biodefense Regulated Quality Review Specialist
3 months ago
Description:
- Work with Chief, RRA, study directors, principal investigators, and other key staff to perform quality reviews of documents and records associated with nonclinical studies, including those conducted under FDA Good Laboratory Practice (GLP) requirements.
- Perform quality review of laboratory study files, SEND packages, and records to ensure that calculations, content, references, etc. are technically correct, verifiable, and complete. This review verifies raw data, spreadsheets, and documents leveraging a representative sample approach as per instructions and USAMRIID SOPs.
- Generate, route, and file a list of major findings for each quality review conducted following SOP requirements and flag minor findings/errors within the raw data or electronically, as requested.
- Represent RRA in study and project team meetings, attend study meetings to facilitate planning, coordination, and communication between technical and quality personnel.
- Stay updated on FDA regulatory requirements and guidance to enhance expertise and conduct internal training to ensure staff and study team personnel are well-trained.
- Write and revise department documents such as SOPs and work instructions, provide peer review, and devise improvements to established procedures to enhance workflow and efficiency.
- Attend conferences to obtain continuing education, provide training to personnel and contractors, maintain and manage supporting systems, processes, and documents.
- Interface directly with the scientific community, categorize, analyze, and report metrics, act as a Point of Contact (POC) for communication issues, perform analysis on collected timelines, act as Subject Matter Expert (SME), represent Quality Review in meetings, and troubleshoot compliance gaps.
- Brief on scientific and regulatory matters, provide training, devise process improvements, maintain GLP training file, and perform other duties as assigned by Supervisor.
Required Degree/Education/Certification:
BS with two to three years of 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 (e.g., 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 rapidly expanding government service provider. Employees benefit from competitive salaries, a 401K plan with company match, comprehensive insurance coverage, tuition reimbursement, paid time off, and 11 paid holidays. The company is an Equal Opportunity/Affirmative Action Employer that values diversity and inclusivity. Accommodations for applicants with disabilities are available upon request. All employees undergo E-Verify. The FOCs, which includes Ke`aki Technologies, Laulima Government Solutions, Kūpono Government Services, and others, are industry-recognized firms committed to providing exceptional service in the government sector. Alaka`ina Foundation's charitable efforts under the 501(c)3 primarily focus on empowering the youth of Hawaii through innovative educational programs that blend leadership, science & technology, and environmental stewardship.
