Quality Specialist Technician - Molecular

NeoGenomics Laboratories; Aliso Viejo (CA); On-site; USD 55,000 - 70,000; Full time

Job summary

NeoGenomics Laboratories in Aliso Viejo, CA is seeking a Quality Specialist Technician - Molecular to drive quality initiatives in laboratory operations. You will collaborate with QA and compliance, ensuring adherence to GLP and applicable CRO standards while supporting regulatory readiness.

The role emphasizes data analysis to detect trends, root cause identification, and corrective actions, with duties spanning document control, sample storage coordination, and cross-department collaboration.

Qualifications

• Bachelor’s Degree from an accredited college or university in chemical, physical, or biological sciences.
• At least one year of laboratory experience, training, or training course.
• Experience in molecular-based testing preferred.
• Experience in Laboratory Quality Program preferred.

Responsibilities

• Maintains awareness of and ensures compliance with regulatory guidelines (CAP, FDA, CLIA, HIPAA, OIG, OSHA, CMS).
• Manages quality control and regulatory requirements for the area (SOPs, proficiency testing, calibration, competency).
• Coordinates quality control activities and monitors adherence to QC measures.
• Analyzes data to detect trends and QC deviations; develops solutions.
• Assists in root cause analysis and corrective action plans to prevent recurrence.
• Maintains digital and physical records including logs, folders, QC documentation and training records.
• Works with Laboratory and Banking Department to coordinate sample storage and archiving.
• Other duties as assigned.

Education

Bachelor’s Degree in chemical, physical, or biological sciences

Job description

Are you motivated to participate in a dynamic, multi-tasking environment? Do you want to join a company that invests in its employees? Are you seeking a position where you can use your skills while continuing to be challenged and learn? Then we encourage you to dive deeper into this opportunity.

We believe in career development and empowering our employees. Not only do we provide career coaches internally, but we offer many training opportunities to expand your knowledge base! We have highly competitive benefits with a variety of HMO and PPO options. We have company 401k match along with an Employee Stock Purchase Program. We have tuition reimbursement, leadership development, and even start employees off with 16 days of paid time off plus holidays. We offer wellness courses and have highly engaged employee resource groups. Come join the Neo team and be part of our amazing World Class Culture!

NeoGenomics is looking for a Quality Specialist Technician for our Molecular department in Aliso Viejo, CA who wants to continue to learn in order to allow our company to grow.

Shift time: 10:00am-6:30pm, Sunday-Thursday or Tuesday-Saturday (subject to change based on business needs)

Now that you know what we're looking for in talent, let us tell you why you'd want to work at NeoGenomics:

As an employer, we promise to provide you with a purpose driven mission in which you have the opportunity to save lives by improving patient care through the exceptional work you perform. Together, we will become the world's leading cancer reference laboratory.

Position Summary:

The Quality Specialist Technician - Molecular is responsible for executing quality initiatives in the laboratory operational disciplines. Assists in the maintenance of a Quality Program utilizing recognized principles of quality assurance and current good laboratory principles (GLP) and as applicable for Clinical Research Organization work (CRO) which NeoGenomics may perform. Reports to Operational management (Supervisor or Manager) but maintains a collaborative/ dotted line partnership and close working relationship with Quality Assurance Department personnel and Compliance.

Core Responsibilities:

• Maintains awareness of and ensures compliance with various regulatory guidelines i.e., CAP, FDA, CLIA, HIPAA, OIG, OSHA, CMS, etc.
• Manages operational area specific to quality control and regulatory requirements, e.g. continual readiness, standard operating procedures (SOPs), proficiency testing surveys, alternate assessment, correlation studies, calibration verification, competency of testing personnel, etc.
• Coordinates quality control activities as assigned, monitors and ensures adherence to quality control measures
• Analyzes data to detect trends and quality control deviations, recognizes quality control problems and develops solutions, may monitor and sign off on scheduled quality control review
• Assists in root cause analysis, identification of root cause, assists in development of corrective action plan to prevent recurrence and ensure follow up actions
• Maintains digital and physical records including, but not limited to, maintenance logs, personnel folders, reagent/control QC documentation and training/competency records
• Works directly with Laboratory and Banking Department to coordinate sample storage and archiving.
• Other duties as assigned

Experience, Education and Qualifications:

• Bachelor’s Degree from an accredited college or university in one of the chemical, physical, or biological sciences
• At least one year of laboratory experience, training, or training course

• Experience in molecular-based testing preferred
• Experience in Laboratory Quality Program preferred

See attachment at the end for full job description:

The Clinical Quality Assurance focus specializes in developing, planning and executing audits to ensure compliance with regulatory standards and firm policies & procedures. Manages clinical quality database of observations for analysis, assessment and identifies compliance risk. Reviews pre and post study document and takes corrective action. This role focuses on learning and executing basic, routine tasks that follow clearly defined procedures, with close supervision and detailed instructions, requiring minimal independent judgment and having an impact limited to individual responsibilities with interaction primarily within the immediate team.

Equal employment opportunity, including veterans and individuals with disabilities.

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