Documentation Specialist - Quality Management System
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Job Location:
Coralville, IA - USA
Monthly Salary:
Not Disclosed
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
At Integrated DNA Technologies (IDT) one of Danahers 15 operating companies our work 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.
Our team at Integrated DNA Technologies (IDT) is united by a commitment to collaboration and scientific excellence building on a strong foundation of innovation expertise and reliability. Guided by our vision to help researchers rapidly move from the lab to life-changing advances we work closely with global partners to accelerate progress and genomics breakthroughs across fields like cancer infectious disease rare genetic disorders and more. At IDT youll be part of a culture rooted in continuous learning and improvementwhere your growth fuels our mission to accelerate the pace of genomics and helps shape a healthier brighter future for all.
Learn about the Danaher Business System which makes everything possible.
The Documentation Specialist is responsible for supporting ISO 13485 compliance and daily operations by managing and routing documentation for approvals coordinating validations reviewing records maintaining internal systems and auditing for compliance.
This position reports to the Manager of Manufacturing Compliance and Continuous Improvement and is part of Commercial & Regulated Products located in Coralville IA and will be an on-site role.
In this role you will have the opportunity to:
Partner with manufacturing customer service and quality and regulatory teams to create and manage custom documentation for the ISO 13485 Value Streams.
Maintain document control integrity ensuring version accuracy and traceability by routing documentation through the Electronic Quality Management System (EQMS) for review approval and release.
Conduct periodic audits of controlled copy documentation to ensure procedural compliance.
Issue customer change authorizations and ensure timely communication of updates.
Support internal and external audits by providing accurate and complete documentation which includes batch records job codes and associate training reports and validation records.
The essential requirements of the job include:
Associates degree with 2 years of Life Science work experience
Familiarity with ISO 9001 ISO 13485 and ISO 14644 Certifications and EQMS systems.
It would be a plus if you also possess previous experience in:
Skilled communication with strong writing editing and documentation abilities with proficiency in Microsoft Office especially Word Excel PowerPoint SharePoint and Visio.
Translating complex processes into clear content and collaborating professionally across all levels under pressure.
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IDT a Danaher operating 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 Danaher Benefits Info.
This job is 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:
Unclear Seniority
Key Skills
- Computer Science
- Active Directory
- Clearance
- Facility
- HVAC
- Linux
- Project Management
- Troubleshoot
- Desktop
- Control Systems
- Management System
- Setup
- hardware
- Data Analysis
- Technical Support
