Are you motivated to participate in a dynamic, multi-tasking environment? Do you want to become part of 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.
NeoGenomics is looking for a Quality Systems Lead - Corporate Audits 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:
NeoGenomics Laboratories is comprised of a national team of experts in developing and delivering laboratory diagnostic and clinical trial services with a focus in cancer. It is the common purpose of all NeoGenomics employees to save lives by improving patient CARE through Communication, Accuracy, Reliability, and Efficiency. Our staff physicians, scientists, laboratory professionals, client services representatives, and sales people team up with our clients. Together, we work to solve the medical, scientific, and logistical challenges of making precise diagnoses, aiding in bringing new therapies to market and finding the unusual hallmarks of each patients disease that point the way to proper treatment.
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.
As a Internal Auditor you are responsible for independently conducting corporate quality audits to ensure compliance with applicable domestic and international regulations, and corporate policies and procedures.
- Act as Lead Quality Internal Auditor for NeoGenomics Laboratories across all sites in US, Europe and Asia, as per defined schedule.
- Perform evaluations of NeoGenomics quality systems and practices to identify potential problems of non-conformance to applicable SOPs and quality standards (GLP, ICH, ISO, and FDA etc.).
- Prepare audit reports and communicate findings to internal partners.
- Oversee resolutions and provide guidance on quality/compliance risk levels.
- Evaluate the adequacy of the provided response evidence against the standards, regulations and approved NeoGenomics procedures. In conjunction with management, develop plans to address inadequate responses.
- Track audit responses and any resulting CAPA until resolution and closeout.
- Provide periodic reports to management on audits status and defined metrics.
- Evaluate, standardize and improve internal audit processes using appropriate industry standard quality improvement techniques
- Work with the Quality Team members to write Quality policies and procedures in the appropriate format; support NeoGenomics Team members with developing and controlling new and revised documents.
- Support Quality team during regulatory inspections.
- Assist with QA training for Jr. Level QA staff and NeoGenomics staff in general.
- Maintain a high degree of personal professional development through a combination of internal and external training, and participation in professional associates as appropriate.
- Additional Responsibilities (may be assigned):
- Conducts external/supplier audits to applicable requirements.
- Perform Quality audits of data generated from Clinical Research department prior to data release to customer.
- Leads and/or supports projects for continuous improvement to ensure compliance with regulations and current industry standards.
- Participates in development of QA programs, policies, procedures and controls.
Act as a backup host for client and regulatory audits.
Education, Experience & Required Qualifications:
- Education: BS/BA in Science, or Pharmaceutical studies or equivalent discipline.
- Experience: 5+ years experience of relevant pharmaceutical, medical device or biotechnology experience in Quality Assurance.
- Minimum of 5 years experience conducting audits per FDA 21CFR820 and ISO13485:2016
- 4 years experience leading internal or external audits in pharmaceutical, medical device or biotechnology organization.
- Knowledge of GxP, FDA regulations, 21 CFR Part 11, 210, 211 and 820 compliance.
- Excellent verbal and written communication skills.
- Comprehensive and in-depth understanding of FDA/GLP/GCP/ICH Guidelines, relevant regulations and standards affecting medical/pharmaceutical industry.
- Experience conducting internal audits within laboratory setting.
- Detail-oriented, confirmed problem solver and analytical thinker with extraordinaryTravel to domestic NeoGenomics sites will be 50 - 75%, with overnight and possible international travel required.Travel to domestic NeoGenomics sites will be 50 - 75%, with overnight and possible international travel required. organization skills.
- Demonstrates the ability to review investigations, change control, analytical data, test reports, and certificates of analysis and other technical documents.
- Demonstrates the ability to conduct focused quality incident investigations.
- Shows ability to train new auditors.
- Ability to work under deadline pressure and extra hours if needed on assignments.
- Proficient using MS Office programs.
- Ability to travel out of town for audits, inspections and off-site meetings.
- Ability to work independently, displaying good judgment and decision making.
- Demonstrated skills to handle a variety of assignments simultaneously.
- Must be able to work in a biohazard environment and comply with safety policies and standards outlined in the Safety Manual.
- Travel to domestic NeoGenomics sites will be 50 - 75%, with overnight and possible international travel required.