Quality Compliance Specialist
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.
Lonza Walkersville is currently recruiting for a Quality Compliance Specialist. This role will be responsible for supporting the Quality Compliance Manager and Lead Quality Compliance in ensuring plant-wide compliance to all applicable cGMP regulatory standards. Responsible for supporting the Corrective and Preventive Action (CAPA) program and Auditing program, including, but not limited to, internal, supplier, customer and 3rd party registrar audits. Individual should be able to work independently with little direction to manage CAPA and other Quality Systems records. Position will also support Metric reporting, Inspection Readiness activities and QMS related trainings. The individual is expected to interact with Bioscience and LAL Management, QA and Operations leadership and prepare written and verbal communication as needed. Knowledge and experience in aseptic drug product manufacturing regulations, medical device quality management system regulations and internal auditing preferred.
- Provide oversight, coach, mentor and train others to ensure non conformances are properly identified, investigated to determine root cause and remediated through the Quality system.
- Provide support to subject matter experts to assure CAPAs are appropriately initiated, progressed and completed with sufficient documented evidence and effectiveness plan.
- Assess and monitor the effectiveness of CAPAs with area subject matter experts.
- Ensure that current CAPA standard operating procedures meet the requirements of US and international regulations for drugs and medical devices including 21CFR820 and ISO 13485. Monitor deviation and CAPA trends and continuously assess the health of the system and escalate adverse trends to quality and operations management.
- Provide support to subject matter experts to assure Audit Observations and other QMS records (currently TrackWise) are progressed and completed with sufficient documented evidence.
- Contribute in the training and management of other quality system processes.
- Provide support during regulatory or client audits as Deviation/CAPA subject matter expert.
- Provide support during customer or internal audits as a member of the Audit team.
- Perform other duties as assigned.
- A minimum of a Bachelor’s degree in Lifesciences is required.
- Substantial year of experience in GMP compliance expertise including knowledge of 21CFR210, 211, 820; the PIC/S 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, ISO 13485:2016 is required.
- Substantial years of experience in Quality Assurance/CAPA Management is required.
- Independent work skills and a strong work ethic
- Team oriented and promoting of others
- Ability to interface and communicate directly with customers and regulatory bodies
- Excellent written and oral communication to include accurate and legible documentation skills
- Ability to work in a fast-paced environment
- Ability to effectively manage multiple projects
- Microsoft Office and database management
- Organization and Record Keeping
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.