Job Description
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 Quality Assurance, Therapeutics Gene Editing (Tx) 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:
- Lead IDT Tx’s Change Control, Internal Audit and Quality Events/CAPA programs
- Responsible for implementing, maintaining and improving IDT Tx’s Quality Management System in accordance with cGMPs for drug substance manufacturing (ICH Q7, 21CFR210/211) and regulatory guidance documents.
- Oversees QMS Key Performance Indicators and associated operating mechanisms, problem-solving when necessary.
- Responsible for timely completion of review and/or investigation into Corrective Action Preventive Actions and other Quality Event Investigations (Nonconformances/OOS/OOT, Customer Complaints, Deviations).
- Interacts professionally and efficiently with manufacturing and support staff; administrate/coordinate the intra-department functionality of the eQMS with departments throughout the facility.
The essential requirements of the job include:
- Bachelor’s degree in a life science related field or technical discipline
- A minimum of five (5) years of experience working in a Quality role.
- Experience working in a GMP compliant facility such as biotech, pharma (drug product or drug substance) or medical device manufacturing is required.
It would be a plus if you also possess previous experience in:
- Experience in validation such as process validation, IQ/OQ/PQ, or cleaning validation preferred
- Auditor certification a plus
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