QA Specialist, Operations — 12-Hour Shift (Tampa)

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

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.