Quality Specialist
NeoGenomics Laboratories
 Aliso Viejo, CA

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 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 Audit Specialist for our Aliso Viejo, CA location who wants to continue to learn in order to allow our company to grow.

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.

Core Responsibilities

  • Support NeoGenomics Pharma Services onsite external audits, regulatory audits and NeoGenomics internal audits to assure timely scheduling and execution of the audit schedule
  • Manage the inspection backroom during regulatory inspections to facilitate the timely delivery of requested documents and support readiness activities for external audits.
  • Support inspection readiness audits prior to external client audits to ensure compliance. Includes inspection readiness and audit participation for selected areas as applicable. Works with functional team leaders for audit readiness.
  • Conducts assigned internal audits as per defined schedule, documents audit findings, reports to Management and coordinates follow-up activities as required.
  • Conduct mock interviews for subject matter experts (SMEs) during inspection preparation
  • Support Clinical Trials/Pharma by supporting and performing QA audits including oversight of specific projects, IT/assay validations, vendor qualification and monitoring as assigned; includes conducting tracer audits.
  • Ensure that quality initiatives, audit findings, measures and corrective action plans are communicated and implemented.
  • Evaluates, standardizes and improves processes using appropriate industry standard quality improvement techniques
  • Responsible for the monitoring, tracking and communication of issues, as well as, documentation of policies and procedures as it pertains to the QMS.
  • Knowledgeable of federal and state laws and regulations concerning clinical laboratory testing procedures and results. (CAP/CLIA, NY State, ISO 15189/13485, FDA 21CFR820)
  • May work with Senior Management, external regulatory agencies, and sponsors during inspections, audits, investigations and report-outs as needed.
  • May write quality-related internal communications.
  • Helps coordinate the implementation of process improvements and educational issues such as the training/retraining of our QMS to employees and new hires; maintain reports, statistics and confidential documentation as assigned.
  • Attends department meetings and company in-service trainings to enhance knowledge on testing and systems.

Position Requirements:

Education: Bachelor of Science in Healthcare related field

Experience: 1+ years’ experience in laboratory regulations, Quality Assurance (QA), or healthcare industry related field.

Qualifications:

  • Knowledge of regulations and standards affecting medical diagnostics.
  • Deadline oriented and ability to work extra hours if needed on assignments.
  • Proficient with MS Office programs
  • Proven problem solver and analytical thinker with exceptional organization skills. Knowledge and exposure to Lean Six Sigma tools preferred.
  • Ability to work independently, displaying good judgment and decision making.
  • Demonstrated skills to handle a variety of assignments simultaneously.
  • Demonstrated skills in training, validation, written/verbal communication, and digital literacy to support the Quality Improvement activities preferred.
  • Must comply with safety policies and standards outlined in the Safety Manual.

All qualified applicants will receive consideration for employment without regard to race, national origin, religion, age, color, sex, sexual orientation, gender identity, disability, or protected veteran status.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

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