Posted in Science 30+ days ago.
This job brought to you by eQuest
Location: Houston, Texas
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.
We strive to be the leading supplier using science and technology to improve the quality of life.
We work with passion, using advanced technologies, to transform life science into new possibilities for our customers.
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.
Bachelors: Scientific or technical discipline required
Minimum of 5 years cGMP environment and related QA field
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.
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.