Quality Control Specialist

MPF Federal seeks a Quality Assurance Specialist/Quality Control 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 QA/QC 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.

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

• Develop and maintain the Quality Management System (QMS), including the eQMS (Media Lab).
• Ensure compliance with applicable regulatory standards (CLIP/CLIA, CAP, FDA, ISO); serve as primary contact for regulatory audits and help prepare and submit necessary documentation and responses.
• Oversee and maintain the Internal Audit Program.
• Oversee and maintain 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.
• Provide 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.
• Perform additional duties and responsibilities as assigned or directed by the supervisor, which may include attendance and participation in required training for the role.

• A bachelor's degree in a science-related field.
• One or more years of quality assurance experience.
• Previous hands-on laboratory bench experience preferred.
• Strong understanding of CLIA/CLIP/CAP regulations and other relevant federal and state guidelines.
• Expertise in developing and implementing Quality Management Systems.
• Experience in conducting internal and external audits.
• Ability to analyze data, identify trends, and conduct root cause analyses.
• Effective communication for reporting findings, training staff, and collaborating with teams and management.
• 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 documentation and SOPs if needed.
• US citizenship and the ability to obtain and maintain a T3/Secret clearance.

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 medical benefits, PTO, holiday pay, and more.

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