Danaher Corporation Quality Systems Coordinator in Coralville, Iowa
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 proud to work alongside a community of nine fellow Danaher Life Sciences companies. Together, we’re pioneering the future of science and medicine, developing products that enable researchers in the fight to save lives.
Job Title: Quality Systems Coordinator
Reports to: Quality Systems Manager
Employment Status: Non-Exempt
Job Profile: O4 - Quality Assurance
Location: Hybrid - Coralville, Iowa
This position is eligible for a hybrid work arrangement in which you can work part of the time at the Company location identified above and part of the time remotely from your home. Hybrid associates must live in an area that does not exceed a 100-mile (150 km) radius of an IDT location. *May require on-site occasional presence for team meetings, etc.
The Quality Systems Coordinator coordinates the activities for establishing the methods used in and the facilities for, the implementation and effective control of manufacturing processes to produce oligonucleotides.
Manufactured products may be included in customer-designated in-vitro diagnostic test kits/systems.
These activities shall be conducted in compliance with the applicable requirements of ISO 9001, ISO 13485, and 21CFR Part 820 FDA Quality Systems Regulations.
May include coordination of QMS activities for ISO certification, customer & regulatory requirements, document & record control, training, audits, nonconforming material, customer complaints, improvement, corrective and preventive action, validation activities, production deviation & change control, and special projects.
Reports to the Quality Systems Manager and is responsible for the coordination and maintenance of a key component of the Quality Management System.
Assures activities for establishing the methods used in and the facilities for, the implementation and effective control of manufacturing processes to produce oligonucleotides reagents (a component to a medical device) for inclusion in customer designed in-vitro diagnostic (IVD) test kits/systems.
Interacts professionally and efficiently with manufacturing and support staff: administrates/coordinates the intra-department functionality of the QMS with customer service, production, integrated supply chain, raw materials QC, chemical processing, analytical QC, engineering, maintenance & calibration, human resources, and supporting activities.
Acts as a quality systems liaison to manufacturing and support departments and assist with investigations into product, process or material complaints.
Prepare reports of quality system performance for management review.
Performs other related responsibilities as needed or assigned.
Develop content for and deliver training on various quality systems functions such as NCR’s, deviations, document control, training system administration and validation activities.
Participation in customer and third-party audits.
- Bachelor’s degree in a related field required.
Three years' professional quality assurance experience in the manufacturing industry required
Experience and familiarity with ISO:9000/13485 standards and FDA QSR/cGMP standards, strongly preferred
Other Job Qualifications
Strong verbal, written, analytical, and persuasive skills and the ability to interact effectively with all levels of employees and management.
Statistical analysis, precision measurement, and process capability studies will become an intricate part of quality assurance programs; therefore, formal education in courses related to these areas such as mathematics, statistics, and industrial practices, may be essential for this position.
What We Offer:
Generous Paid Time Off Accruals
16 Hours PAID Volunteer Time Off
10 Paid Holidays
Up to eight (8) weeks of 100% paid parental leave to eligible U.S. associates
401(k) with Company Match
Medical, Dental, and Vision Insurance Options
Integrated DNA Technologies (IDT) conducts drug screens and background checks on applicants who accept employment offers.
When you join us, you’ll also be joining Danaher’s global organization, where 69,000 people wake up every day determined to help our customers win. As an associate, you’ll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful Danaher Business System (https://www.danaher.com/how-we-work/danaher-business-system) tools and the stability of a tested organization.
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 email@example.com to request accommodation. If you’ve ever wondered what’s within you, there’s no better time to find out.