QA Specialist, Operations - 12hr Day or Night Shift

Lonza; Tampa (FL); On-site; USD 65,000 - 85,000; Full time

Benefits offered by this job

Performance bonus

Medical, dental and vision insurance

401(k) matching

Life insurance

Short-term disability

Long-term disability

Employee assistance programs

Paid time off

Job summary

Lonza in Tampa, FL is seeking a QA Specialist, Operations for a 12-hour shift to support cGMP manufacturing quality assurance. You will review records, approve batch documentation, and participate in investigations and regulatory interactions.

The role emphasizes collaboration across departments and ensuring product quality and safety while maintaining safety and sustainability requirements.

Qualifications

• Bachelor’s degree in a Science or related field or equivalent experience.
• Quality assurance or manufacturing experience required.
• Knowledge of Pharma cGMP standards required.
• Experience in audits and regulatory compliance processes is advantageous.

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.

Skills

QA experience

cGMP knowledge

Attention to detail

Cross-functional collaboration

Regulatory audits

Education

Bachelor’s degree in Science or related field

Tools

Trackwise

SAP

Microsoft Office

Job description

QA Specialist, Operations - 12hr Day or Night Shift

QA Specialist, Operations - 3rd shift

Shift: 12 Hour Shift

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.

Reference: R80056

You will feel at home at Lonza if you:

• Take ownership, step forward, and enjoy meaningful responsibility
• Love solving problems and thrive in a complex, fast-moving environment
• Are curious, always looking to learn and improve
• Work collaboratively, contributing to something bigger than yourself
• Are motivated to make a difference through work that impacts customers and their patients

Why Lonza:

We are a place of unique opportunity, where your ideas, expertise and ambition can make a real difference. Here, will have the freedom to grow, the support to succeed and the chance to contribute to work that matters.

We are the makers of the medicines of tomorrow.