Pharma QA Specialist (3rd Shift) | cGMP Quality Assurance

Lonza Group Ltd.; 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

Disability insurance (short-term &

Employee assistance programs

Paid time off

Job summary

Lonza Group Ltd. in Tampa, FL is seeking a QA Specialist, Operations for the 12-hour night shift to support cGMP compliance and quality assurance across manufacturing. You will review records, assist with deviations, and collaborate with multiple departments to ensure product quality and patient safety.

The role emphasizes strict attention to detail, adherence to SOPs, and participation in audits and regulatory inspections, with comprehensive benefits and a team-oriented environment.

Qualifications

• Bachelor’s degree in a Science or related field or equivalent experience.
• Proficient experience in quality assurance or manufacturing.
• Knowledge of Pharma cGMP standards.
• 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.

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

Quality assurance experience

Manufacturing experience

Attention to detail

Collaborative work

Education

Bachelor’s degree in Science or related field

Tools

Trackwise

SAP

Microsoft Office

Job description

Lonza Group Ltd. in Tampa, FL is seeking a QA Specialist, Operations for the 12-hour night shift to support cGMP compliance and quality assurance across manufacturing. You will review records, assist with deviations, and collaborate with multiple departments to ensure product quality and patient safety.

The role emphasizes strict attention to detail, adherence to SOPs, and participation in audits and regulatory inspections, with comprehensive benefits and a team-oriented environment.