Quality Assurance Specialist

MPF Federal seeks a Quality Assurance Specialist/Quality Control Specialist to support the Naval Health Research Center (NHRC), Operational Infectious Diseases (OID) Directorate. Reporting to the Contract Program Manager and under the mentorship of the Sr. Laboratory Manager, this role oversees the Quality Management System, ensures compliance to regulatory standards, and makes continuous improvements.

The NHRC OID is seeking a meticulous and proactive Quality Assurance/Quality Control Specialist to manage and maintain the integrity of critical research regulatory compliance and documentation. This vital role is responsible for ensuring the accurate and secure storage, retrieval, and control of all laboratory records, SOPs, batch records, and other essential documentation related to operational infectious disease research. The QA/QC Specialist will play a key role in supporting quality assurance efforts, maintaining regulatory compliance, and facilitating efficient data management practices. This position requires a strong understanding of quality systems, exceptional attention to detail, and the ability to collaborate effectively with cross-functional teams to ensure the highest standards of data quality and regulatory adherence.

The OID Directorate conducts biosurveillance, clinical trials, research, and diagnostic testing to protect our warfighters, their families, and the homeland against infectious diseases and promote global health security. OID maintains a CLIP (Clinical Laboratory Improvement Program) and CAP (College of American Pathologists) accredited laboratory to support all categories of testing.  Test specimens are collected and tested in accordance with their respective study protocols, and results are provided to the applicable sponsors, the Armed Forces Health Surveillance Center, local investigators and collaborators, ordering physicians, and county health units to guide proper responses that ultimately affect both the readiness of US forces and the safety of public health. 

COMPENSATION: $65-70k annually (this is a non-exempt hourly role)

Responsibilities

·       Develops and maintains the Quality Management System (QMS), including the eQMS (MediaLab).

·       Ensures compliance with applicable regulatory standards (CLIP/CLIA, CAP, FDA, ISO); serves as primary contact for regulatory audits and help prepare and submit necessary documentation and responses. 

·       Oversees and maintains the Internal Audit Program.

·       Oversees and maintains the Document Control and Record Retention programs, including maintaining a centralized documentation system for all records, ensuring that data and records are securely stored, easily accessible, and meet regulatory and organizational standards.

·       Oversee and maintain the nonconforming event system, including investigation of complaints, conducting root cause analyses for identified issues, and ensuring corrective and preventative actions (CAPA) are implemented effectively.

·       Provides training and orientation to new and existing laboratory staff on quality standards, regulatory requirements, and procedures.

·       Work with management to identify areas for process improvement and implement changes to enhance the quality of laboratory services.

·       Performs additional duties and responsibilities as assigned or directed by the supervisor, which may include attendance and participation in required training for the role.

Qualifications

• A bachelor’s degree in a science-related field.
• One or more years of quality assurance experience.
• Previous hands-on laboratory bench experience preferred.
• Knowledge of Regulations: Strong understanding of CLIA/CLIP/CAP regulations and other relevant federal and state guidelines.
• Quality Systems: Expertise in developing and implementing Quality Management Systems.
• Auditing Skills: Experience in conducting internal and external audits.
• Analytical Skills: Ability to analyze data, identify trends, and conduct root cause analyses.
• Communication Skills: Effective communication for reporting findings, training staff, and collaborating with teams and management.
• Attention to Detail: Meticulous approach to documentation, data review, and process monitoring.
• Ability to work effectively with cross-functional teams, including researchers, laboratory staff, and auditors.
• QA/QC Specialist to be able to help with any standardization of clinical trials documentations and SOPs if needed.
• US Citizenship and the ability to obtain and maintain a T3/Secret Clearance.

Some positions or sites may require that the incumbent be fully vaccinated against COVID-19, and proof of vaccination may be required.

MPF Federal is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability. We offer a competitive compensation package including a competitive salary, medical benefits, PTO, holiday pay and more.