Staff Clinical Compliance Auditor
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Job Location:
Minneapolis, MN - USA
Monthly Salary:
$ 115 - 135
Posted on:
30+ days ago
Vacancies:
1 Vacancy
Job Summary
Bring more to life.
Are you ready to accelerate your potential and make a real difference within life sciences diagnostics and biotechnology
Within Danaher the work our diagnostic businesses do saves livesand were all united by a shared commitment to innovate for tangible impact.
Youll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danahers system of continuous improvement you help turn ideas into impact innovating at the speed of life.
Were accelerating the development of cutting-edge diagnostics to solve some of the worlds most pressing health challenges. Across our diagnostics operating companies we are driving innovation through partnerships with top academic institutions and leading players in biopharma and translational research. Were bringing the best minds together to accelerate innovation and unlock the full potential of the latest scientific advances. Together were expanding access to precision diagnostics for millions of people worldwide - and were using our unmatched global scale and proven playbook to make it happen from hospital labs to mobile clinics. By helping providers patients and families get faster more precise diagnostic results were improving treatment options and saving lives. Learn about the Danaher Business System which makes everything possible.
This position is part of the Danaher Diagnostics organization and is a remote role. At Danaher Diagnostics our vision is to be the leading provider of seamlessly connected diagnostic solutions.
The Staff Clinical Compliance Auditor (Global Focus - Remote) for Danaher Diagnostics is responsible for clinical quality and compliance. This includes study audit and inspection management activities across the Clinical Center of Excellence (CCOE).
You will be a part of the Clinical Compliance team and report to the Sr. Director of Global Clinical Compliance responsible for clinical quality and scientific writing to support new product research across four diagnostic operating companies within Danaher Diagnostics. If you thrive in a fast-paced high impact role and want to work to build a world-class audit-ready Clinical organizationread on.
In this role you will have the opportunity to:
- Plan and execute internal audits of clinical trials sites vendors and systems and support external audits or regulatory inspections.
- Lead a comprehensive schedule of audits to ensure Bioresearch Monitoring (BIMO) inspection and notified body (NB) audit readiness.
- Lead the investigation of clinical quality issues deviations and non-conformances managing the CAPA process to ensure effective resolution.
- Provide expert guidance and training to clinical study teams and other relevant staff on compliance requirements best practices and the clinical QMS.
- Monitor changes in relevant regulations and guidelines assessing their impact on clinical operations and updating internal procedures accordingly.
The essential requirements of the job include:
- Bachelors degree with 6 years clinical quality experience within diagnostics or medical device industry or Masters or Doctoral degree with 4 years of the same experience.
- 4 years of clinical quality auditing experience or a combination of clinical project auditing and clinical study experience.
- In depth understanding of ISO in vitro diagnostic regulation (IVDR) medical device regulation (MDR) and pertinent sections of 21 CFR.
- Highly motivated to work in a fast-paced environment with effective use of prioritization organization problem-solving and time management skills.
It would be a plus if you also possess previous experience in:
- Certified auditor (e.g. ASQ CQA or ASQ CBA GCP)
- The technology and assays related to in vitro Diagnostic (IVD) across one or more of the following areas: chemistry immunoassay hematology microbiology or flow cytometry.
Danaher Diagnostics a Danaher company offers a broad array of comprehensive competitive benefit programs that add value to our lives. Whether its a health care program or paid time off our programs contribute to life beyond the job. Check out our benefits at .
Within Danaher Diagnostics we believe in designing a better more sustainable workforce. We recognize the benefits of flexible remote working arrangements for eligible roles and are committed to providing enriching careers no matter the work arrangement. This position is eligible for a remote work arrangement in which you can work remotely from your home. Additional information about this remote work arrangement will be provided by your interview team. Explore the flexibility and challenge that working within Danaher Diagnostics can provide.
The annual salary range OR the hourly range for this role is $115K-$135K. This is the range that we in good faith believe is the range of possible compensation for this role at the time of this posting. This range may be modified in the future.
This job is also eligible for bonus/incentive pay.
We offer comprehensive package of benefits including paid time off medical/dental/vision insurance and 401(k) to eligible employees.
Note: No amount of pay is considered to be wages or compensation until such amount is earned vested and determinable. The amount and availability of any bonus commission benefits or any other form of compensation and benefits that are allocable to a particular employee remains in the Companys sole discretion unless and until paid and may be modified at the Companys sole discretion consistent with the law.
Join our winning team today. Together well accelerate the real-life impact of tomorrows science and technology. We partner with customers across the globe to help them solve their most complex challenges architecting solutions that bring the power of science to life.
For more information visit .
Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race color national origin religion sex age marital status disability veteran status sexual orientation gender identity or other characteristics protected by law.
The U.S. EEO posters are available here.
We comply with federal and state disability laws and make reasonable accommodations for applicants and employees with disabilities. If reasonable accommodation is needed to participate in the job application or interview process to perform essential job functions and/or to receive other benefits and privileges of employment please contact:1- or .
Required Experience:
Staff IC
Key Skills
- Auditing
- Time Management
- ICD-10
- Accounting
- Component evaluation
- Workers' Compensation Law
- SOX
- Microsoft Excel
- CPT Coding
- Internal Audits
- Medicare
- Bookkeeping
About Company
WHO WE ARE We are a global science and technology innovator committed to helping customers solve complex challenges and improving quality of life around the world. These are the moments that make a difference. Performing a delicate operation on an unborn baby. Minimizing waste at ever ... View more
