Quality Specialist

Quality Assurance Aliso Viejo, California Ft Myers, Florida Houston, Texas Durham, North Carolina Flexible


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 who wants to continue to learn in order to allow our company to grow.     

Flexible work arrangement, with at least 3 days/week onsite.    

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:     

This role performs complaint and nonconformance investigations, works with cross-functional teams to develop corrections and corrective and preventive action plans, and drives investigations and Corrective and Preventive Actions (CAPAs) to closure.     

Core Responsibilities:     

Assists with daily operational aspects of the Investigation/Complaints/CAPA Process     

 Employ risk analysis tools to determine appropriate internal and external corrections, corrective actions, and/or preventive actions required     

Thoroughly document all aspects of the investigation, complaint, and CAPA process to develop an audit-ready record     

Collaborates with the Quality Management team to review and finalize monthly and quarterly complaint and CAPA metrics. Run ad hoc reports as necessary     

 Provide general training to the global CAPA team and other applicable users as necessary     

 Participates as a CAPA subject matter expert during internal and external audits     

 Identify and assist with the implementation of updates to the applicable QMS software module(s); including participating in validation efforts     

 Assists in the preparation and execution of site/global Management Review meetings     

 Knowledgeable of federal and state laws and regulations concerning clinical laboratory testing procedures and results. (CAP/CLIA, NYDOH, ISO 15189/13485, 21CFR820)     

 Responsible for the monitoring, tracking and communication of issues, as well as, documentation of policies and procedures as it pertains to the QMS     

 Up to 25% domestic/international with some overnight travel may be required.     

Requirements:     

Bachelor’s Degree     

 Bachelor’s Degree field in Life Sciences, Engineering, or an equivalent field of study preferred.     

 One year of relevant experience     

 Six Sigma Certified Green Belt, preferred     

 Experience performing CAPA investigations, documentation and performing effectiveness verifications of CAPAs.     

 Must exhibit strong and effective communication skills.     

 Must have excellent and effective writing skills.     

Must be able to maintain a high activity level, and be able to effectively manage and prioritize numerous projects and responsibilities.     

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.

Pay Range (will vary based on location & experience) $58,508 - $94,990 annually, plus bonus