Quality Assurance Specialist
Job Title: Quality Assurance Specialist
GW DOC # G2025-01684
Overview
Psomagen, Inc. is seeking a QA Specialist with experience in the clinical laboratory industry to join our Clinical Services team. This individual will primarily handle domestic and international regulatory affairs, focusing on CLIA, ISO, GCLP, and GLP regulations. Additionally, the specialist will support quality assurance activities and be adaptable to other assigned tasks.
Job Profile
• Full-time
• Location: Rockville, MD
Key Responsibilities
• Stay current with all regulatory procedures and documentation to maintain compliance with CLIA, ISO, GCLP, GLP , and customer requirements.
• Monitors, tracks pre-analytical, analytical, and post analytical performance, and directly report to the technical supervisor and laboratory director.
• Conducts internal/external audits to verify compliance to regulations and standards.
• Reviews, maintains Corrective Action Logs, and ensures corrective actions are completed documented, tracked, and trended.
• Conveys QA/QC data and audit findings in a concise and professional manner.
• Write, review, and update SOPs, verification/validation Protocols, and Reports.
• Maintains Proficiency Testing (PT) records, receipt of PTs, tracking PT assignments, pre-submission review, and review of the post evaluation reports.
• Develop or validate laboratory workflows according to CLIA/CAP regulation.
• Collaborate with the R&D team to implement cutting-edge sequencing technologies and methodologies.
• Perform other duties and responsibilities as assigned or directed by the supervisor.
Qualifications
• Bachelor’s degree in biological science or related field.
• Previous experience s in quality assurance and regulatory affairs for clinical settings.
• Strong understanding of CLIA, ISO, GCLP, and GLP regulatory requirements and experience working in a CAP/CLIA accredited laboratory.
• Strong understanding of regulatory requirements and quality assurance in a clinical laboratory setting
Preferred Skills
• Excellent laboratory, technical, communication and interpersonal skills.
• Ability to work independently once trained and maintains excellent records with a keen attention to detail.
• Excellent record keeping and organizational skills.
• Proficiency in computer software including Word, Excel, and PowerPoint.
• Proven expertise in next-generation sequencing (NGS) technologies and bioinformatics tools.
• Korean language skill
Benefits
• Medical, dental, and vision insurance (Monthly insurance premium is covered 100% by the employer)
• 401K with immediate participation and company match after 1 year
• 24 days of paid time-off with up to 12 roll-over or cashing-out option. Time office also includes all Federal holidays.
• Additional vacation is awarded to long-term service
• 2 hours off for an annual check-up
• Money Gifts for Congratulatory/Condolences
• Lunch allowance and drinkware reimbursement
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 (Korean stock exchange market) in July 2020, the company is rapidly expanding its business from B2B to B2C and from Research to Clinical markets. The company has broadened its 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 expanding service offerings further in the clinical laboratory diagnostics market such as a laboratory-developed test (LDT) for COVID-19
How To Apply
Please email all resumes to hr@psomagen.com with the email title "[Application] Quality Assurance Specialist".
Biotechnology Research
Quality Assurance
Full-time