QA Specialist, Operations - 2nd Shift

Shift: M-F 3-11

Today, Lonza is a global leader in life sciences operating across five 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.

Job Description:

Developing professional who assists and supports the organization with initial compliance and ongoing preparation, testing and monitoring of conformance to established quality assurance processes and standards for manufacturing. Alternatively, conducts internal production/process and manufacturing quality control audits and risk assessments.  

Key Responsibilities:

• Performs document reviews of SOPs, batch records, test methods, protocols, deviations, CAPA, component specification 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.  Approves SOPs, Master Batch Records and executed batch records.   
• Approves / Releases Laboratory Data and Reports. 
• Assesses potential impact to product quality for open deviations during lot release.  
• May participate in investigations into minor and major root cause, corrective or preventive actions and impact to product safety, identity, strength, quality or purity.
• Participates in internal audits, vendor audits and customer audits. Provides back room support during regulatory audits and inspections.  
• May lead internal or external audits. Interact with different departments to solve issues to achieve department goals.  Support all areas to achieve company goals.  
• Attend client meetings and calls  
• 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 

Key Qualifications:

• Bachelors Degree in a Science or related field
• 3+ years of relevant work experience
• Pharma cGMP preferred
• Trackwise, SAP, and Microsoft Office preferred

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.