Quality Specialist Technologist - Molecular

NeoGenomics Laboratories; Durham (NC); On-site; USD 85,000 - 105,000; Full time

Job summary

NeoGenomics Laboratories, Inc. in Durham, NC is seeking a Quality Specialist Technologist for the Molecular team to advance quality initiatives and ensure robust laboratory practices.

The role supports internal audits, CAPA processes, document control, and staff training, while working under minimal supervision to uphold quality imperatives. A strong background in high-complexity testing and state licensing is required, with ASCP certification preferred.

Qualifications

• Bachelor’s degree or equivalent with license to perform lab testing.
• Experience in high complexity testing and regulatory compliance.
• Current state licensure in FL, CA and TN where applicable.
• ASCP certification or eligibility preferred for the specialty.

Responsibilities

• Perform core duties of a Clinical Laboratory Technologist while supporting departmental quality initiatives
• Represent the department in quality meetings and communicate updates, expectations, and initiatives to staff
• Serve as the department’s Quality SME and liaison to the Quality team on processes and systems
• Facilitate adoption of quality initiatives and updates within the department
• Support document control processes ensuring SOPs, forms, and records are current and accurate
• Maintain staff assignments to quality groups to ensure proper distribution of SOPs
• Assist in training and competency programs and track documentation
• Support CAPA, deviations, complaints, investigations, and follow-up activities
• Participate in CAPA Review Board meetings and follow-up as requested
• Perform internal audits, inspections, and support external audits with timely closure of findings
• Coordinate proficiency testing and root cause analysis for unacceptable results
• Monitor compliance with internal policies and regulatory requirements and support inspection readiness

Education

Bachelor’s Degree in Chemical, Biological, or Clinical Laboratory Science, Medical Technology or Biomedical Sciences or equivalent work experience required

4+ years of experience in high complexity testing

FL current state license to perform laboratory testing required

CA current state license to perform laboratory testing required

TN current state license to perform laboratory testing required

Nationally ASCP certification or eligibility when applicable to the assigned specialty certification preferred

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 Technologist for our Molecular team in Durham, NC who wants to continue to learn in order to allow our company to grow.

Shift time: 9:00am-5:30pm, either 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 Technologist works under minimal supervision and demonstrates

proficiency in core responsibilities of a Clinical Laboratory Technologist and performs duties as

assigned. This is the advanced level for the Technologist job category responsible for assisting

the department supervisor/manager who are ultimately responsible for the execution of quality

imperatives. The Quality Specialist Technologist assists in the implementation of key priorities

and supports quality requirements and initiatives in department operations.

Core Responsibilities:

• Ability to perform core duties of a Clinical Laboratory Technologist while supporting ddepartmental quality initiatives
• Represent the department in quality meetings and communicate updates, expectations, and initiatives to department staff
• Serve as the department’s Quality SME and primary liaison to the Quality team, providing guidance on quality requirements, processes, and systems
• Facilitate communication and adoption of quality initiatives and updates within the department
• Support document control processes by ensuring SOPs, forms, and records are current, accurate, and aligned with departmental practices
• Maintain appropriate staff assignment to quality groups to ensure correct distribution and acknowledgment of SOPs and quality documents
• Act as a resource for staff navigating document control systems (e.g., MediaLab) and support related workflows
• Partner with department leadership to support training and competency programs, including assignment, tracking, and documentation
• Assist in ensuring completion of training and competency requirements within established timelines
• Support execution of quality event processes (e.g., CAPA, deviations, complaints), including reporting, investigation support, and staff guidance
• Participate in CAPA Review Board meetings and support follow-up activities as requested
• Perform internal audits and inspections, support external audits, and ensure timely follow-up, documentation, and closure of findings
• Coordinate proficiency testing and alternative assessment activities, including documentation and root cause analysis for unacceptable results
• Monitor compliance with internal policies and regulatory requirements, manage change control activities, and support overall inspection readiness and quality system documentation
• Perform other duties as assigned by department Supervisor / Manager or Laboratory Director

Experience, Education and Qualifications:

• Bachelor’s Degree in Chemical, Biological, or Clinical Laboratory Science, Medical Technology or Biomedical Sciences or equivalent work experience required
• 4 or more years of experience in high complexity testing required
• Understanding of general laboratory techniques with emphasis on department specific techniques FL current state license to perform laboratory testing required
• FL current state license to perform laboratory testing required
• CA current state license to perform laboratory testing required
• TN current state license to perform laboratory testing required
• Nationally ASCP certification or eligibility when applicable to the assigned specialty certification preferred