Danaher Corporation Document Control Coordinator in Coralville, Iowa
Integrated DNA Technologies (IDT) is the leading manufacturer of custom oligonucleotides and proprietary technologies for genomics applications. Our work is complex and cutting-edge, and our team members are curious, creative thinkers who understand that good data drives smart decisions. At IDT, we realize that although science may be uniform, people are unique. We promote a culture where engaged people are motivated and have opportunities to achieve their full potential, as part of one global team.
IDT is one of 10 Life Sciences companies of Danaher. Together, we accelerate the discovery, development and delivery of solutions that safeguard and improve human health.
This position is part of the Genomic Medicines Quality Assurance department located in Coralville, IA and will on-site at 2400 Oakdale Blvd. At IDT, we are one global team. We celebrate our differences, engage in healthy debate, and are inclusive. Together, we accomplish great things.
In this role, you will have the opportunity to:
Manage and execute the initiation, processing, routing, distribution and archiving of cGMP documentation, as well as manage the document change control process, coordinating cross functional reviews, approvals, and effective dates in alignment with cGMP requirements and customer needs.
Serve as subject matter expert for the electronic document management system and learning management system, function as training coordinator for cGMP operations (Genomic Medicines).
Coordinate with Supply Chain, Operations, and Quality Control to issue batch production documents to meet production schedule needs.
The essential requirements of the job include:
High school diploma or equivalent
2+ years of experience in the pharmaceutical and/or biopharmaceutical industry (or related regulated industry)
Minimum of at least 1 year experience working with a document control system
It would be a plus if you also possess previous experience in:
Working with electronic document management systems.
Working knowledge of cGMPs or quality regulations including ICH Q7, 21 CFR210/211, etc. and FDA guidance documents
Good decision making and problem-solving skills, demonstrated understanding of cGMPs, ability to apply cGMPs and recognize variances from cGMPs.
At Danaher we bring together science, technology and operational capabilities to accelerate the real-life impact of tomorrow’s 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. Our global teams are pioneering what’s next across Life Sciences, Diagnostics, Biotechnology and beyond. For more information, visit www.danaher.com.
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. We value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.
The EEO posters are available here (https://www.dol.gov/agencies/ofccp/posters) .
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform crucial job functions, and to receive other benefits and privileges of employment. Please contact us at firstname.lastname@example.org to request accommodation.