Lonza

Lead QA Specialist, Operations - 3rd Shift

US - Tampa, FL Full time

Lead QA Specialist – 3rd Shift

Location: Tampa, FL

Join Lonza’s Tampa site as a key leader within our Quality Assurance Operations team. This 3rd shift role (11:00 PM – 7:30 AM, Sunday through Thursday) offers the opportunity to drive operational quality overnight, ensuring uninterrupted compliance and oversight across critical manufacturing activities.

What you will get:

A competitive compensation. In addition, below you will find a comprehensive summary of the benefits package we offer:

  • Performance-related bonus.

  • Medical, dental and vision insurance.

  • 401(k) matching plan.

  • Life insurance, as well as short-term and long-term disability insurance.

  • Employee assistance programs.

  • Paid time off (PTO).

Compensation for this role will be determined by the candidate’s qualifications, skills, experience, and relevant knowledge.

What you will do

  • Lead, mentor, and develop a team of QA Operations personnel supporting 3rd shift activities.

  • Ensure QA presence on GMP manufacturing and packaging floors, providing guidance during quality-critical operations.

  • Review SOPs, batch records, test methods, and logbooks to ensure cGMP activities are accurately completed.

  • Approve SOPs, Master Batch Records, customer audit items, and regulatory CAPAs.

  • Oversee QA activities to ensure alignment with company SOPs, cGMP requirements, and FDA regulations.

  • Assess the impact of open deviations on product quality and support root cause investigations and CAPA implementation.

  • Recommend and support improvements to processes, programs, and QA workflows.

What we are looking for

  • 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.

  • Experience in QA, manufacturing operations, or laboratory operations—preferably within pharma or biotech.

  • Strong understanding of cGMP, FDA regulations, and quality documentation practices.

  • Demonstrated leadership capability including coaching, mentorship, or team supervision.

  • Skilled in problem-solving and conducting root cause investigations.

  • Ability to work cross-functionally and support overnight operations with autonomy.

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.