What are the responsibilities and job description for the Stability Program Specialist position at Integrated DNA Technologies (IDT)?
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.
The Stability Program Specialist is part of the Quality Assurance, Therapeutics Gene Editing department located in Coralville, Iowa and will be on-site at our Therapeutics Manufacturing facility. 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:
- Write, execute, and maintain stability protocols, reports and SOPs in support of the stability program, including review and implementation of regulatory requirements for the stability program.
- Coordinate with Quality Control management for scheduling of stability sample analysis and organizing shipments to off-site laboratory facilities (as needed).
- Ensure data is evaluated, including the creation, review and trending of data, to meet customer, industry and regulatory requirements and presenting data in graphical form and reports provided to customers
- Assist in the preparation of documents for and provide support during customer and/or regulatory audits.
- Performs other duties as assigned.
The essential requirements of the job include:
- Bachelor’s degree in a scientific field
- Minimum 1-2 years of experience in a regulated environment or GMP compliant environment (Pharmaceutical, Medical Device, OTC Drug, Cosmetic, etc.)
- Experience with basic statistical analysis, and related interpretation of stability data
It would be a plus if you also possess previous experience in:
- Experience working in a quality control laboratory or quality assurance role a plus.
- Working knowledge of regulatory guidance for stability storage and testing, desired
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 Company's sole discretion unless and until paid and may be modified at the Company’s sole discretion, consistent with the law.
#LI-LCS
Join our winning team today. Together, we’ll 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.
For more information, visit www.danaher.com.
