QA Specialist III QA Support for QC
Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s 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 that’s the kind of work we want to be part of.
This individual will review and approve Quality Control (QC) documents including test records, lab investigations, system suitability, assay qualification, and stability records. Performs QA on the floor reviews for the QC laboratory at the site. Interact directly with internal and external customers to obtain documentation required for document processing. The individual also manages investigations or change controls as owner or QA approver. Performs master document review and approval.
- Performs QA on the floor reviews for the Quality Control (QC) laboratory at the site.
- Reviews and approves executed QC documentation (test records, lab investigations, system suitability, stability reports, assay qualification protocols/summary reports, environmental monitoring, etc.)
- Interact directly with internal and external customers to obtain documentation required for document processing.
- Manages deviations and change controls as owner or QA approver in Trackwise system.
- Writes/revises/approves master documents Ex. Forms, Standard Operating Procedures (SOPs), specifications, etc.
- Applies GMP knowledge to ensure that QC processes comply with effective procedures and regulatory requirements.
- Maintains compliance with all required training and assists with training of fellow analysts.
- Performs project related tasks as assigned.
- Bachelors in Life Sciences required.
- Experience in Quality Operations (5+ years)
- Experience with cGMP environment (5+ years)
- Previous QA experience in a pharmaceutical industry required (4+ years)
- Commercial experience preferred.
- 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.
- Technical Writing, Root Cause Analysis, Microsoft Office applications,
- TrackWise, DMS, SAP and LIMS systems, preferred.
- Ability to manage multiple projects concurrently, time management skills.
- Good Manufacturing Process compliance knowledge and related QA field
Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.
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 as a qualified individual with disability, protected veteran status, or any other characteristic protected by law.