Stability Program Specialist
Stability Program Specialist
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Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
Integrated DNA Technologies (IDT) is the leading manufacturer of custom oligonucleotides and proprietary technologies for genomics applications. Our work is complex and cuttingedge 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 onsite 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 offsite 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:
- Bachelors degree in a scientific field
- Minimum 12 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 Companys sole discretion unless and until paid and may be modified at the Companys sole discretion consistent with the law.
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Join our winning team today. Together well accelerate the reallife 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. 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.
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 to request accommodation.
Required Experience:
Unclear Seniority
Employment Type
Full-Time
