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QA Specialist IV at Lonza America Inc

Posted in Science 30+ days ago.

This job brought to you by eQuest

Type: Full-Time
Location: Houston, Texas





Job Description:

At Lonza, we invest in great people. We encourage our employees to challenge themselves and we offer an environment that fosters creativity and success. Headquartered in Basel, Switzerland, we operate production, R&D, and business sites around the world, including Europe, North America, and Asia. 

Our vision:

We strive to be the leading supplier using science and technology to improve the quality of life.

Our mission:

We work with passion, using advanced technologies, to transform life science into new possibilities for our customers.
 

Do you want to help us as we shape the future of this great organization?

 

Job Description Summary

Job Description Summary

Responsible for all activities involving quality assurance and compliance with applicable regulatory requirements. A wide degree of creativity and latitude is necessary. Hours will be M-F (mid shift) 10:00 AM - 7:00 PM after training is completed.

Job Responsibilities:


  • Verification of the company’s compliance with ISO/cGMP quality system requirements as well as knowledge of 21CFR210, 211, 610 and the PICS Guide to Good Manufacturing Practices Part 1 and 2 or the EU Guidelines to Good Manufacturing Practice Medicinal Products for Human and Veterinary Use, including Annex 1.

  • Provide immediate support to operations and quality control staff to address compliance related concerns (QA “on-the-floor” support).

  • Make independent quality-related decisions based on regulatory and compliance knowledge and provide independent quality support to project teams.

  • Audit internal quality system elements in manufacturing and operational support areas.

  • Provide oversight for compliance of Change Controls, CA/PA and investigations, OOS and deviations.

  • Act as a customer interface during on-site audits, conference calls and other standard means of communication.

  • Independently identify and manage special projects or QA compliance functions as agreed upon with QA management.

  • Prioritize and manage a variety of projects simultaneously.

  • Review and approve validation documents.

  • Review of Master Batch Records (MBR) and supporting documents. Perform review/release of batch records, as needed.


  • Minimum Required Qualifications/Skills

    Education


    Bachelors: Scientific or technical discipline required    


    Experience


    Minimum of 5 years cGMP environment and related QA field


    Knowledge


    GMP compliance knowledge including knowledge of 21CFR210, 211, 820 and the PICS Guide to Good Manufacturing Practices Part 1 and 2 or the EU Guidelines to Good Manufacturing Practice Medicinal Products for Human and Veterinary Use, including Annex 1 and FDA Guidance on Aseptic Processing; ISO 9001:2015, 13485 and Part 11 compliance knowledge preferred.


    Skills


    Managerial skills, Technical Writing, Root Cause Analysis, Microsoft Office applications, TrackWise, DMS, SAP and LIMS systems, preferred


    Qualities & Attitude


    Ability to manage multiple projects concurrently; time management skills.



 

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 as a qualified individual with disability, protected veteran status, or any other characteristic protected by law.

 

Lonza.  The place to Go, Stay and Grow.