Quality Regulatory Compliance Specialist Job

Quality Regulatory Compliance Specialist

Employer: Psomagen, Inc.
1330 Piccard DR, Suite 103, Rockville, MD 20850
Duty:
1. Regulatory Compliance Management (30%)
Coordinate and implement the company’s regulatory compliance programs to meet the requirements of the U.S. Food and Drug Administration (FDA), Clinical Laboratory Improvement Amendments (CLIA), College of American Pathologists (CAP), and International Organization for Standardization (ISO); Maintain awareness of regulatory updates and ensure all operations remain compliant with applicable federal and state regulations; Stay current with all regulatory procedures and documentation to maintain compliance with CLIA, ISO, GLP (Good Laboratory Practice), GCLP(Good Clinical Laboratory Practice), and customer requirements.
2. Audit and Inspection Coordination (25%)
Plan, coordinate, and execute internal and external audit activities to ensure continuous compliance with federal, state, and accreditation requirements under Clinical Laboratory Improvement Amendments (CLIA), College of American Pathologists (CAP), International Organization for Standardization (ISO), and U.S. Food and Drug Administration (FDA) regulations; Conduct comprehensive internal audits, reviewing Standard Operating Procedures (SOPs), test records, validation files, equipment logs, and personnel training documentation for completeness, accuracy, and compliance; Prepare and present documentation for internal and external audits; Coordinate responses to audit findings, track corrective actions, and ensure that regulatory agencies and accrediting bodies’ observations are addressed within required timelines.
3. Quality Management System Administration (25%)
Manage and maintain the company’s Quality Management System (QMS), including controlled documents, validation records, and Standard Operating Procedures (SOPs); Oversee implementation of the Corrective and Preventive Action (CAPA) program, ensuring timely documentation and resolution of quality issues; Maintain audit-ready validation files and controlled documents in the company’s Quality Management System (QMS) and ensure proper version control.
4. Training on Regulatory Compliance (20%)
Develop, implement, and oversee regulatory and quality-related training programs for all laboratory and administrative personnels to ensure full compliance with applicable standards and internal procedures; Identify training needs based on regulatory updates, audit findings, and process changes affecting CLIA, CAP, ISO, and FDA requirements; Create and maintain training curricula, covering quality management principles, data integrity, document control, equipment validation, biosafety, and corrective and preventive action (CAPA) processes.

Minimum Job Requirements

• Bachelor of Science degree in biological sciences or pharmaceutical sciences and 12 months of post-graduate experience as Regulatory Compliance Specialist or laboratory technician

Area of Employment: Rockville, MD 20850

The Offered Salary: $65,000.00 per year [Health Insurance, 401(k)]

Please send resume to [email protected]

This job posted on 04/30/2026 and expires on 05/10/2026