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Internal Auditor

Company: NeoGenomics Laboratories
Location: Aliso Viejo
Posted on: November 18, 2021

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 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 an Internal Auditor 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.Summary:The Internal Auditor is a critical position within the Quality department that is responsible for independently conducting corporate quality audits ensuring compliance with applicable domestic and international regulations, and corporate policies and proceduresResponsibilities:* Act as 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, FDA etc.).* Prepare audit reports and communicate findings to internal stakeholders.* Coordinate 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.Experience & Required Qualifications:Education: Bachelor of Science in healthcare related field required* 3+ years of relevant pharmaceutical, medical device or biotechnology experience in Quality Assurance; prior experience in a CAP/CLIA environment preferred.* Experience leading internal or external audits in a relevant pharmaceutical, medical device, biotechnology or healthcare setting.* Knowledge of GxP, FDA regulations: 21 CFR Part 493, Part 11, Part 210 and Part 211.Qualifications:* 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, proven problem solver and analytical thinker with exceptional 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 25-50%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.

Keywords: NeoGenomics Laboratories, Aliso Viejo , Internal Auditor, Accounting, Auditing , Aliso Viejo, California

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