Overview
Biodefense Regulated Quality Review Specialist Jobs in Frederick, Maryland, USA at Laulima Government Solutions
Job Title:
Biodefense Regulated Quality Review Specialist
The Alaka`ina Foundation Family of Companies (FOCs) is seeking a qualified Biodefense Regulated Quality Review Specialist to support our contract with USAMRIID in Frederick, Maryland.
The candidate will provide Quality Review (QR) support to USAMRIID’s Medical Countermeasure (MCM) Advanced Test & Evaluation (T&E) capability, including 100% data audits and verification of final reports for both well documented and GLP compliant studies.
Responsibilities:
Review data, spreadsheets, tables, figures, SEND packages, and final reports to ensure completeness and compliance, including sampling per USAMRIID SOPs.
Collaborate with study directors, investigators, and staff to perform quality reviews of nonclinical study documents, including those under FDA GLP requirements.
Verify laboratory study files, SEND packages, and records for accuracy and completeness for QA audits.
Document major findings and flag minor errors during reviews.
Review GLP study final reports for technical accuracy and completeness for submission and QA audits.
Participate in study and project meetings, and attend GLP study kick-offs.
Assist in sponsor and regulatory inspections as needed.
Apply scientific and regulatory expertise to support assignments and team activities.
Stay updated on FDA regulations and conduct internal training for staff.
Draft and revise SOPs and work instructions, and suggest process improvements.
Attend conferences for continuing education and maintain current GLP training records.
Provide regulatory training to USAMRIID personnel.
Manage supporting systems, metrics, and documentation related to quality review activities.
Communicate with scientific teams regarding raw data, findings, and corrective actions.
Implement procedural improvements to enhance efficiency and compliance, including BSL-2 environment observations.
Perform other duties as assigned.
Qualifications:
Education: BS with 2-3 years of relevant experience.
Skills & Experience:
Experience in Quality Control/Review within a GLP environment.
Familiarity with FDA Animal Rule and SOP management.
Experience with incident investigation and QA audits.
Desired
Skills:
Previous DoD experience.
Experience with assays such as ELISA and HPLC.
Citizenship & Clearance:
U.S. Citizen.
Ability to obtain NACI clearance.
We offer competitive salaries, a 401K with match, comprehensive health benefits, tuition reimbursement, paid time off, and holidays. We are an Equal Opportunity Employer and support accommodations for persons with disabilities. For more information, visit
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Title: Biodefense Regulated Quality Review Specialist
Company: Laulima Government Solutions
Location: Frederick, Maryland, USA
Category: Quality Assurance – QA/QC (Data Analyst), Healthcare (Data Scientist)
