Quality Assurance Specialist

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.

Required Knowledge, Skills, and Abilities:

• Excellent laboratory, technical, communication and interpersonal skills.
• Ability to work independently once trained and maintains excellent records with a keen attention to detail.
• Knowledge of CLIA, ISO, GCLP, and GLP regulatory requirements and experience working in a CAP/CLIA accredited laboratory.
• 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.

Benefits

Medical, dental, and vision insurance (Monthly insurance premium is covered 100% by the employer)

• 401(k) plan + company match up to 5% after one year
• 24 days of paid time-off with roll over or cashing option
• 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