Quality Regulatory Compliance Specialist

Psomagen Inc•Rockville, MD

14h•Onsite

About The Position

Are you seeking an opportunity where you can support regulatory excellence and quality compliance in a well-established laboratory environment? Do you want to apply your knowledge and experience to ensure adherence to regulatory standards in a growing biotechnology company? If you are eager to contribute to maintaining high-quality standards alongside a collaborative team, join Psomagen’s quality and compliance team. Psomagen Inc. is a rapidly growing biotechnology company renowned for providing a variety of genomics-based molecular assay solutions to research and clinical communities. We are seeking a highly motivated Quality Regulatory Compliance Specialist to support regulatory compliance programs, audit readiness, and quality management system operations. The ideal candidate will play a key role in ensuring compliance with FDA, CLIA, CAP, and ISO requirements, coordinating audits, maintaining quality systems, and supporting training initiatives. This role will contribute to maintaining regulatory excellence and ensuring high-quality operational standards across the organization.

Nice To Haves

Bachelor of Science degree in Biological Sciences, Pharmaceutical Sciences, or a related field
Minimum of 12 months of post-graduate experience as a Regulatory Compliance Specialist or Laboratory Technician
Strong understanding of regulatory frameworks such as FDA, CLIA, CAP, and ISO standards
Knowledge of Quality Management Systems (QMS) and compliance documentation practices
Strong organizational, analytical, and documentation skills
Excellent communication and collaboration skills

Responsibilities

Coordinate and implement regulatory compliance programs in accordance with FDA, CLIA, CAP, and ISO requirements
Monitor regulatory updates and ensure company operations remain compliant with applicable federal and state regulations
Maintain regulatory documentation and ensure compliance with GLP (Good Laboratory Practice), GCLP (Good Clinical Laboratory Practice), and internal requirements
Plan, coordinate, and execute internal and external audits to ensure compliance with regulatory and accreditation standards
Conduct internal audits by reviewing SOPs, test records, validation files, equipment logs, and training documentation
Prepare audit documentation and coordinate responses to audit findings, ensuring timely resolution of corrective actions
Manage and maintain the Quality Management System (QMS), including controlled documents, validation records, and SOPs
Oversee the Corrective and Preventive Action (CAPA) program, ensuring timely documentation and resolution of quality issues
Maintain audit-ready documentation and ensure proper version control within the QMS
Develop and implement regulatory and quality training programs for laboratory and administrative personnel
Identify training needs based on regulatory updates, audit findings, and operational changes
Maintain training materials related to quality management, data integrity, biosafety, and compliance processes