QA Specialist, Operations - 12 hour shift

Location: Tampa, Florida, USA

Schedule

3rd shift: 11:00 p.m.–7:30 a.m., Sunday through Thursday

About the role

Join our team in Tampa, FL, where you’ll play a key role in ensuring compliance with cGMP standards and supporting quality assurance processes for manufacturing. This is an exciting opportunity to contribute to product quality and safety while collaborating across multiple departments.

Responsibilities

• 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.

Requirements

• 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.

Benefits

• 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)

About the company

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.