Senior Quality Assurance Auditor
United States, Walkersville (Maryland)
Today Lonza is a global leader in life sciences. We are more than 15,000 employees in more than 100 locations around the world. 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 Senior Quality Assurance Auditor identifies quality issues, monitors progress toward resolution of deficiencies, and verifies effectiveness of corrective action. Prepares an annual internal audit plan for all applicable areas, processes, systems based on risk, and includes any site assessments as defined by Lonza Global Quality (LGQ).
- Plans and performs assigned internal audits approved by senior management.
- Generates and distributes the audit report within the required timeframe.
- Assists Subject Matter Experts (SMEs) with initiating Corrective and Preventive Actions (CAPAs) within the required timeframe in accordance with procedures.
- Executes the audit plan to ensure timely completion.
- Updates the audit plan when required, including justification for any changes.
- Prepares an annual internal audit report. Individual should be able to work independently with little direction to prepare written and verbal communication.
- Reviews and follows up with the responses within the required timeframe for all types of internal audits.
- Participates in the development of action plans to correct deficiencies and improve quality processes.
- Supports regulatory or client audits as host, front room or backroom manager.
- Supports management of CAPAs related to internal audits, customer audits, and regulatory inspections.
- Revise or approve SOPs related to audit observations and audit program.
- Assigned duties according to specified procedures and receives detailed instructions.
- Performs a variety of routine work within established policies and procedures, and receives detailed instructions on new projects and assignments.
- Receives little instruction on day-to-day work and receives general instructions on new assignments, objectives, and receives guidance in terms of broad goals.
- Establishes methods and procedures for attaining specific goals
- Only the final results of work are typically reviewed.
- Exercises wide latitude in determining objectives and approaches to critical assignments.
- Bachelor’s degree in life sciences required. Preferred area of study: Life Sciences
- QA experience and a working knowledge of cell culture and aseptic processing experience required.
- Experience performing internal audits and third party audit management required.
- Experience with oversight of aseptic processing and the associated international.
- Aseptic processing regulations and medical device regulations.
- 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.
- Working Knowledge of endotoxin testing required.
- Auditing Certification a plus.
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.