11 days old

Specialist, Quality Systems

US01 Lonza Inc.
Fort Smith, AR 72901
  • Job Code

Today Lonza is a global leader in life sciences. We are more than 15,000 employees in more than 100 locations around the world. While we work in science, theres no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And thats the kind of work we want to be part of.

In accordance with written and oral instructions, the Quality Systems Specialist will provide support to the Ft. Smith UCII operations for oversight of dietary supplements and food regulations. This position will provide the primary administration, reporting and oversight of major quality systems for the UCII facility.

Key responsibilities:

  • Administration of Quality Systems to include: Master Data, Deviations, Complaints, Change Control, Internal Auditing, Supplier Auditing, HARPC and CAPA.
  • Conduct and manage training compliance to include GMP.
  • Host audits and respond to audit findings.
  • Responsible for compiling and reporting monthly metrics related to quality systems.
  • Assist Quality Manager in developing annual quality plan and quality summit.
  • Oversight of Policy/SOP/SOI/WI compliance.
  • Development of procedures and controls in support of the Quality Management System.
  • Identify and implement potential improvement projects, as appropriate.
  • Final Approval/Disposition of batch records and ensure compliance to master batch record. Manage Product Specification Sheet and Certificate of Analysis approval and compliance.

Key requirements:

  • Bachelors degree, preferably in Business or Science related field.
  • Minimum of 5 years of experience in a QA/QC position in a regulated industry.
  • Demonstrated ability to lead and train other associates.
  • Excellent communication skills (both written and verbal)
  • Proven ability to independently prioritize tasks
  • Proficient with Microsoft Office (Excel, Work, Outlook, PowerPoint)
  • 2 3 years dietary supplement, food or pharmaceutical experience
  • Experience with implementation of quality systems
  • Working knowledge of 21 CFR 111 and 21 CFR 117
  • Experience with customer and regulatory audits/inspections

People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.

Lonza is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status

Posted: 2019-11-25 Expires: 2019-12-24
Sponsored by:
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Sponsored by:
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Specialist, Quality Systems

US01 Lonza Inc.
Fort Smith, AR 72901

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