- Perform timely and thorough review of all batch documentation to ensure that all documentation is complete, accurate, and that it conforms to all regulatory and statutory requirements for release. Work with staff across multiple departments during review, correction, and finalization of documentation. Effectively communicate decisions and rationale utilized during review and approval of manufacturing, quality control, and release documentation internally and to customers.
- Perform disposition of products and materials, including incoming materials, components, labeling, intermediates, bulk, and final packaged products. Disposition is inclusive of hold, reject and/or release. Serve as the Quality expert and ensure any product that does not meet specification is dispositioned appropriately.
- Develop, implement, and participate in continued improvement of GMP compliant procedures. Able to assess and review SOPs and forms to determine compliance to a standard.
- Assist in preparation of documents for and provide support during customer and/or regulatory audits.
- Performs other duties as assigned.
- Bachelor's degree in a scientific or engineering field
- 2+ years of experience in a regulated environment or GMP compliant environment
- Experience working in a quality management system (QMS) required.
- Experience working in a pharmaceutical and/or biopharmaceutical industry (or related regulated industry).
- Working knowledge of cGMPs or quality regulations including ICH Q7, 21 CFR210/211, etc., preferred.
- Good decision making and problem-solving skills, demonstrated understanding of cGMPs, ability to apply cGMPs and recognize variances from cGMPs.
- Experience working with or working understanding of quality control laboratory testing and equipment, highly desired.
Shift Differentials (Extra Compensation for less traditional shifts)
Generous Paid Time Off Accruals
16 Hours PAID Volunteer Time Off
11 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
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QA Specialist, Product Quality - Des Moines, United States - Danaher
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 department located in Coralville, Iowa and will be on-site at 2400 Oakdale Boulevard. 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:
The essential requirements of the job include:
It would be a plus if you also possess previous experience in:
What We Offer:
Integrated DNA Technologies, a Danaher company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives. Whether it's a health care program or paid time off, our programs contribute to life beyond the job. Check out our benefits at
#LI-LCS
At Danaher we bring together science, technology and operational capabilities to 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. Our global teams are pioneering what's next across Life Sciences, Diagnostics, Biotechnology and beyond. 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.
