QA Specialist, Operations - 12 hr shift

Lonza; Tampa (FL); On-site; Confidential; Full time

Benefits offered by this job

Performance-related bonus

Medical, dental and vision insurance

401(k) matching plan

Life insurance

Short-term and long-term disability

Employee assistance programs

Paid time off

Job summary

Lonza in Tampa, FL is seeking a QA Specialist, Operations on the 3rd shift to help ensure product quality and regulatory compliance within a cGMP manufacturing environment. You will review SOPs, batch records, test methods and deviations, and support batch release processes across cross-functional teams.

You will approve SOPs, Master Batch Records, lab data reports, and participate in investigations, audits and regulatory inspections.

Qualifications

• Bachelor's degree in a Science field or equivalent experience.
• Proficient experience in quality assurance or manufacturing.
• Knowledge of Pharma cGMP standards.
• Familiarity with Trackwise, SAP, and Microsoft Office.
• Strong attention to detail and collaborative work style.
• Audits and regulatory compliance experience is advantageous.

Responsibilities

• Review SOPs, batch records, test methods, and deviations to ensure cGMP compliance.
• Approve SOPs, Master Batch Records, and lab data reports.
• Assess product quality impact for open deviations during lot release.
• Participate in investigations, audits, and support regulatory inspections.
• Collaborate with cross-functional teams to resolve issues and hit goals.
• Attend client meetings to support quality initiatives.
• Ensure safety and sustainability requirements are met and issues are corrected.

Skills

Quality Assurance

cGMP knowledge

Regulatory compliance

Audits

Education

Bachelor's degree in Science

Tools

Trackwise

SAP

Microsoft Office

Job description

QA Specialist, Operations - 3rd shift

United States, Tampa (Florida)

Shift:

11:00p-7:30a Sunday through Thursday

Location:

Tampa, Florida, USA.

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.

What You Will Get

• 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).

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?

Reference: R80123