Quality Regulatory Compliance Specialist

Position Summary

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.

Job Profile

• Full-time 
• Location: Rockville, MD

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

Preferred Qualifications

• 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

Benefits

• Medical, Dental, and Vision insurance (100% employer-paid premium) 
• 401K with immediate participation and company match after 1 year 
• Paid time-off with roll over option 
• Long-term employment cashable vacation 
• 2-hour off for an annual check-up 
• Lunch allowance and drinkware reimbursement 
• Visa sponsorship is offered when needed 
• Money Gifts for congratulatory/condolences
• Free gym facilities near the company

Company Overview 

Psomagen, Inc., founded in 2004 in Rockville, MD, is at the forefront of genetic and genomic testing. The company offers cutting-edge genomic services through next-generation and Sanger sequencing with data analysis services for applications in basic research and clinic diagnostics. The service laboratory has been certified under the Clinical Laboratory Improvement Amendments (CLIA) and accredited by the College of American Pathologists (CAP), which demonstrates the highest level of quality and safety in the market.

Listed on the KOSDAQ in July 2020, the company is rapidly expanding its business from B2B to B2C and from Research to Clinical markets. The company has broadened the capabilities in the healthcare space such as at-home kits for analysis of genetic traits and microbiome profiles. With CLIA-certified and CAP-accredited laboratories, the company is looking to further expand service offerings in the clinical laboratory diagnostics market such as a laboratory-developed test (LDT) for COVID-19.