Quality Assurance Specialist

Job Title: Quality Assurance Specialist

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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:

• Fulltime
• Location: Rockville MD

Key Responsibilities:

• Stay current with all regulatory procedures and documentation to maintain compliance withCLIA ISO GCLP GLP and customer requirements.
• Monitors tracks preanalytical 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 presubmission 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 cuttingedge sequencing technologies and methodologies.
• Perform other duties and responsibilities as assigned or directed by the supervisor.

Qualifications:

• Bachelors degree in biological science or related field.

• Previous experiencesin quality assurance and regulatory affairs for clinical settings.
• Strong understandingofCLIA ISO GCLP and GLPregulatory 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 nextgeneration 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 timeoff with up to 12 rollover or cashingout option. Time office also includes all Federal holidays.
• Additional vacation is awarded to longterm service
• 2 hours off for an annual checkup
• 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 cuttingedge genomic services through nextgeneration 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 athome kits for analysis of genetic traits and microbiome profiles. With CLIAcertified and CAPaccredited laboratories the company is expanding service offerings further in the clinical laboratory diagnostics market such as a laboratorydeveloped test (LDT) for COVID19

How to Apply

Please email all resumes to with the email title Application Quality Assurance Specialist.