Quality Systems Program Lead | Houston

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 Systems Program Lead for our Houston, TX 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.

The Quality Systems Program Lead is directly responsible for implementing and maintaining the effectiveness of specific quality systems for the organization. This position collaborates with the Sr. Manager Quality Systems to maintain a constant state of regulatory compliance and ensuring customer satisfaction by providing outstanding quality services.

Responsibilities:

* Ensure that quality initiatives, measures and corrective action plans are communicated and implemented.
* Facilitates/manages assigned quality systems/programs such as Internal/External Audits, Document Control, Training/Competency, Records and Change Management
* Evaluates, standardizes and improves processes using appropriate industry standard quality improvement techniques
* Conducts assigned internal audits as per defined schedule, documents audit findings, reports to Management and coordinates follow-up activities as required.
* Support Clinical Trials/BioPharma by performing QA audits including oversight of specific projects, IT/assay validations, vendor qualification and monitoring as assigned.
* Works with the Quality Team members to write Quality protocols in the appropriate format. Supports NeoGenomics Team members with developing and controlling new and revised documents.
* Participates in the translation of internal and external customer needs into products and process requirements; identifies issues affecting customer satisfaction and recommends programs to address those issues and prevent defects.
* Ensures that practices, activities and projects support Quality and business strategies; provides advice to resolve issues where precedents exist; recognizes and removes barriers to project or task completion.
* Ensures all necessary metrics, statistics, and documentation needed for oversight agencies including CAP and any other regulatory agencies for all NeoGenomics facilities are available.
* Coordinates the development of Corporate Quality and Customer directives with local procedures.
* Responsible for the monitoring, tracking and communication of issues, as well as, documentation of policies and procedures as it pertains to the QMS.
* 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.
* Facilitates the training and competency assessment program for all technical staff in coordination with the respective department management so as to ensure all are completed as scheduled.

Experience & Required Qualifications:

* Bachelor of Science in healthcare related field required
* 3+ years' experience in laboratory regulations, Quality Assurance (QA), or healthcare industry related field.
* Knowledgeable of federal and state laws and regulations concerning clinical laboratory testing procedures and results. (CAP/CLIA, NY State, ISO 15189/13485, FDA 21CFR820)
* Demonstrated Quality related leadership and management responsibilities.
* Ability to work under deadline pressure and extra hours if needed on assignments.
* Proficient with MS Office programs
* Detail-oriented, proven problem solver and analytical thinker with exceptional organization skills. Knowledge and exposure to Lean Six Sigma tools preferred.
* Ability to travel out of town for inspections and off-site meetings.
* Ability to work independently, displaying good judgment and decision making.
* Demonstrated skills in training, validation, written/oral communication, and computer skills to support the Quality Improvement activities preferred.
* Must be able to work in a biohazard environment and comply with safety policies and standards outlined in the Safety Manual.