What are the responsibilities and job description for the Lead Quality Assurance Coordinator position at Danaher Manufacturing?
Step into Innovation with Integrated DNA Technologies (IDT)!
At IDT, we don’t just follow trends in genomics, we set them. Our unparalleled expertise in custom oligonucleotides and pioneering technologies empowers scientific advancements and truly propels human health solutions forward. Join us in Coralville, Iowa, and become a key player amid a vibrant atmosphere that champions both individuality and collaboration under the esteemed Danaher Corporation, alongside nine other Life Sciences companies.
About the Role: As a Lead Quality Assurance Coordinator, your role is crucial in our Therapeutics Gene Editing (Tx) department. Your mission will encompass spearheading the Change Control, Internal Audit and Quality Events/CAPA initiatives at our Therapeutics Manufacturing hub. Ensuring compliance with cGMP standards and embracing a proactive approach to regulatory adherence, you'll be central to maintaining and elevating our Quality Management System.
Key Responsibilities:
- Champion Change Control, Quality Events, Internal Audits, and CAPA programs.
- Enhance and sustain our Quality Management System to meet cGMPs and other regulatory frameworks.
- Monitor and analyze QMS performance with strategic problem-solving when necessary.
- Complete timely reviews/investigations of corrective actions, preventives actions, and quality events.
- Efficiently manage internal relationships and eQMS functionalities across departments.
Qualifications:
- Bachelor’s in a life science field or related technical discipline.
- Minimum 5 years in a Quality role, with a focus on GMP-compliant settings.
Bonus Experience:
- Strong preference for experience in process, IQ/OQ/PQ, or cleaning validation.
- Auditor certification is advantageous.
Join us, where science meets inspiration and drive meets opportunity. Your potential is limitless at IDT!
