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QA Specialist, Product Quality

Company: Integrated DNA Technologies (IDT)
Location: Coralville
Posted on: May 24, 2023

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. Job Title: QA Specialist, Product Quality Location: Coralville, IA (On site) Purpose: This position is part of the Quality Assurance department located in Coralville, IA and will be onsite. You will be a part of the Quality Assurance Team and report to the Director of Quality Assurance. The primary responsibilities of this role will be to interface with other members of the Quality Assurance (QA) team, Quality Control (QC), and Operations to complete review of manufacturing and quality control documentation in order to disposition materials. This individual will perform timely reviews of all batch documentation; assure that batch records are complete, correct, and meet all current Good Manufacturing Practices (cGMP) and all current Good Documentation Practices (cGDP); and confirm all critical process parameters (CPPs) and critical quality attributes (CQAs) have been met to assure product quality is protected. Upon completion of review, this individual will determine if the evidence supports release and if the materials are suitable for use and shipping. In this role, you will have the opportunity to:

  • 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.
  • 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.
  • Release manufacturing rooms following required review of records and after confirming acceptance criteria have been met.
  • Effectively communicate decisions and rationale utilized during review and approval of manufacturing, quality control, and release documentation internally and to customers. Communicate issues, events, and resolution with internal and external customers as appropriate.
  • 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 a documents for and provide support during customer and/or regulatory audits.
  • Demonstrates behavior consistent with the Integrated DNA Technologies Core Values.
  • Performs other duties as assigned. Qualifications and Experience:
    • Bachelor's degree in a scientific field, required .
    • 2+ years of experience in a regulated environment or GMP compliant environment, required.
    • Experience working in a QMS required.
    • Experience working in a pharmaceutical and/or biopharmaceutical industry (or related regulated industry), preferred.
    • Working knowledge of cGMPs or quality regulations including ICH Q7, 21 CFR210/211, etc., preferred.
    • Ability to work independently with initiative, good planning and organizational skills, flexibility for changes in work priorities and amount of activities.
    • Good decision making and problem-solving skills, demonstrated understanding of cGMPs, ability to apply cGMPs and recognize variances from cGMPs.
    • Strong verbal, written, analytical, and persuasive skills and the ability to interact effectively with all levels of employees and management. 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 .
      • 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 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 80,000 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 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 .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. If you ve ever wondered what s within you, there s no better time to find out.

Keywords: Integrated DNA Technologies (IDT), Cedar Rapids , QA Specialist, Product Quality, Other , Coralville, Iowa

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