QA Specialist, Operations - 12hr Day or Night Shift
Full Job Posting
What you will do
- Review SOPs, batch records, test methods, protocols, deviations, CAPA, and related documentation to ensure compliance with cGMP standards.
- Approve SOPs, Master Batch Records, executed batch records, and laboratory data reports.
- Assess product quality impact for open deviations during lot release.
- Participate in investigations, audits (internal, vendor, customer), and provide support during regulatory inspections.
- Collaborate with cross-functional teams to resolve issues and achieve departmental goals.
- Attend client meetings and calls to support quality initiatives.
- Ensure adherence to safety and sustainability requirements, reporting and correcting issues promptly.
- What we are looking for
- Bachelor’s degree in a Science or related field required or equivalent experience.
- Proficient experience in quality assurance or manufacturing required.
- Knowledge of Pharma cGMP standards required.
- Familiarity with Quality Management Systems such as Trackwise, SAP, and Microsoft Office tools.
- Strong attention to detail and ability to work collaboratively across teams.
- Experience in audits and regulatory compliance processes is advantageous.
About Lonza
At Lonza, our people are our greatest strength. With 30+ sites across five continents, our globally connected teams work together every day to manufacture the medicines of tomorrow. Our core values of Collaboration, Accountability, Excellence, Passion and Integrity reflect who we are and how we work together. Everyone’s ideas, big or small, have the potential to improve millions of lives, and that’s the kind of work we want you to be part of.
Innovation thrives when people from all backgrounds bring their unique perspectives to the table. At Lonza, we offer equal employment opportunities to all qualified applicants regardless of race, religion, color, national origin, sex, sexual orientation, gender identity, age, disability, veteran status, or any other characteristic protected by law. If you’re ready to help turn our customers’ breakthrough ideas into viable therapies, we look forward to welcoming you on board.
Ready to shape the future of life sciences? Apply now.
Qualifications
- Bachelor’s degree in a Science or related field required or equivalent experience.
- Familiarity with Quality Management Systems such as Trackwise, SAP, and Microsoft Office tools.
About Lonza
Lonza is a global supplier to the pharmaceutical, biotech, and nutrition markets, providing contract development and manufacturing services, specialty ingredients, and advanced technologies.
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