QA Specialist II
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 is hiring a Quality Assurance Specialist II for our 1st shift team (M-F). The incumbent will assist and support the organization with initial compliance and ongoing preparation, testing and monitoring of conformance to established quality assurance processes and standards for manufacturing. Alternatively, conduct internal production/process and manufacturing quality control audits and risk assessments.
- Perform document reviews of SOP’s, batch records, and logbooks to ensure cGMP activities are completed and documented in accordance with approved, written procedures. May also review raw materials, work orders, validation and MSAT reports.
- Independently approve SOPs, Master Batch Records, customer audit and regulatory CAPA.
- Participate in investigations into minor major root cause, corrective or preventive actions and impact to product safety, identity, strength, quality or purity.
- Perform additional job-related assignments as requested by management
- Adhere to all defined Safety and Sustainability requirements and expectations and seek clarification whenever Safety and Sustainability requirements and expectations are either unknown or unclear
- Promptly report identified Safety and Sustainability issues, problems, deficiencies, errors, incidents, and/or opportunities to management and correct where possible
- Stop work where deemed necessary to maintain safety
- Bachelor’s degree in science, preferably chemistry
- Significant experience in a Pharma cGMP environment in Quality Assurance
- Solid experience with Quality systems prefer TrackWise, SAP and Documentum
- MS office suite knowledge, prefer intermediate level excel, Powerpoint and word
- Demonstrated time management experience
- Good oral and written communication skills
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