Diagnostic Solutions Laboratory, LLC ยท 11 hours ago
Quality Assurance Technician
Diagnostic Solutions Laboratory is committed to advancing clinical testing that improves patient care. The Quality Assurance Technician plays a critical role in ensuring the accuracy, integrity, and reliability of clinical laboratory results by monitoring clinical data and supporting quality improvement initiatives.
BiopharmaBiotechnologyClinical TrialsPharmaceuticalPrecision Medicine
Responsibilities
Perform data analysis across multiple clinical testing platforms to identify trends, anomalies, and quality indicators
Monitor laboratory practices to ensure adherence to quality standards, SOPs, and Good Clinical and Laboratory Practices (GCLP)
Review and manage quality documentation, including reagent Certificates of Analysis (CoAs), deviation reports, incident reports, training records, and related controlled documents
Support internal and external audits to ensure compliance with CLIA, state regulations, OSHA, and other applicable regulatory bodies
Assist in identifying systemic or recurring quality issues and recommend process improvements to mitigate nonconformance events
Maintain regulatory and audit readiness through accurate documentation management, including procedures, training records, validation files, and personnel records
Support root cause analyses (RCAs) and corrective and preventive action (CAPA) development in collaboration with laboratory management
Conduct preliminary investigations into customer complaints related to laboratory quality or testing results
Collaborate with cross-functional teams to support implementation of quality improvement initiatives
Monitor data integrity and ensure compliance with HIPAA and data privacy requirements
Perform additional duties as assigned to support an effective quality assurance and quality control program
Qualification
Required
Bachelor of Science degree from an accredited university in a biological or related scientific field, or equivalent experience
Basic mathematical and statistical skills, including the ability to interpret and analyze data trends
Working knowledge of Good Clinical and Laboratory Practices
Demonstrated ability to collaborate effectively across functional areas
Exceptional attention to detail and commitment to data accuracy
Strong problem-solving skills with a results- and solution-oriented mindset
Ability to work independently as well as collaboratively in a team environment
Excellent organizational and time-management skills
Superior written and verbal communication abilities
Understanding of statistical principles and quality metrics
High level of integrity and demonstrated experience with HIPAA compliance
QA: 1 year (Required)
Ability to Relocate: Alpharetta, GA 30005: Relocate before starting work (Required)
Preferred
Prior experience in a clinical laboratory setting, either in testing operations or quality control/assurance
Experience with LIMS systems and web-based laboratory applications
Ability to communicate effectively with staff and leadership at all organizational levels
Benefits
401(k)
401(k) matching
Dental insurance
Health insurance
Life insurance
Paid time off
Vision insurance
Company
Diagnostic Solutions Laboratory, LLC
Our Mission: To deliver innovative, accurate and clinically relevant diagnostic testing in a timely and cost-effective manner.
Funding
Current Stage
Early StageRecent News
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