Quality Assurance Specialist IV
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 IV(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.
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.
- Provide immediate support to operations and quality control staff to address compliance related concerns (Quality Assurance “on-the-floor” support).
- Make independent quality-related decisions based on regulatory and compliance knowledge and provide independent quality support to project teams.
- Provide oversight for compliance of Change Controls, Corrective and Preventative Action, investigations, Out of Specification 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 Quality Assurance compliance functions as agreed upon with Quality Assurance management.
- Prioritize and manage a variety of projects simultaneously.
- Review and QA approve GMP master documents and executed GMP documents from QC, manufacturing, material management, FE, validation and any other department that supports lot production.
Key requirements:
- Bachelors: Scientific or technical discipline required
- Intermediate experience (5+ years) in pharmaceutical, biotechnology or related industry
- Intermediate (5+ years) Quality Assurance experience within Bio/Pharma industry
- 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
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.