Quality Assurance Specialist III - 2nd Shift (3pm-12am)
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.
The Quality Assurance Specialist III (QA) - Quality Operations represents the QA department on internal and external meetings ensuring that quality requirements are met. Support manufacturing operations and all support groups related to manufacturing execution. Supports investigations using problem solving tools as owner or QA approver. Supports execution and closure of corrective actions and change controls as owner or QA approver. Review and QA approve General Manufacturing Practices (GMP) master documents and executed GMP documents from Quality Control (QC), manufacturing, material management, FE, and any other department that supports lot production. Other duties include tracking quality records, participation in internal/external audits, QA on the floor execution, room releases, and overall cGMP compliance.
This position reports on-site Mon-Fri (3pm-12am). Additional Shift Differential is Offered
Key responsibilities:
- Verification of the company’s compliance with International Organization for Standardization/ Good Manufacturing Process (ISO/cGMP) quality system requirements as well as knowledge of 21 Code Federal Regulation 210, 211, 610 and the pharmaceutical inspection Co-operation Scheme Guide to Good Manufacturing Practices Part 1 and 2 or the European Guidelines to Good Manufacturing Practice Medicinal Products for Human and Veterinary Use, including Annex 1.
- Perform QA walkthroughs and work closely with manufacturing and support groups to resolve any issues identified during the walkthroughs.
- Support activities that involve QA presence on the floor.
- Review executed Batch Records and supporting documents to support batch disposition.
- Perform the Quality Assurance review and approval of GMP documents and Quality systems records (ie: deviations, CAPAs)
- Prioritize and manage a variety of projects simultaneously.
Key requirements:
- Bachelors: Scientific or technical discipline required
- Intermediate experience (3-5 years) in pharmaceutical, biotechnology or related industry
- Intermediate Quality Assurance experience
- Good Manufacturing Process compliance knowledge and related QA field
- Root Cause Analysis, including technical writing.
- Level III Gowning
- On the floor support
- TrackWise, DMS, SAP and LIMS system
- Ability to work onsite 2nd shift hours Mon-Fri 3:00 PM- 12:00 AM
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.