QA Operations Lead – GMP & Packaging

Lonza; Tampa (FL); On-site; USD 85,000 - 120,000; Full time

Job summary

Lonza is seeking an experienced QA professional to support GMP operations on the manufacturing floor, providing guidance and performing documentation reviews to ensure cGMP compliance. The role involves writing and approving SOPs and batch records, and guiding CAPA processes to prevent deviations.

Ideal candidates will have a Bachelor’s degree, 5+ years in QA/manufacturing, and 1–2 years of leadership experience in pharma or biotech settings, with a commitment to safety and quality on site.

Qualifications

• Bachelor’s degree or higher with preference for related science field.
• 5+ years of experience in QA/manufacturing environments.
• 1–2 years of leadership experience in a GMP setting.
• Experience in pharma/biotech QA preferred; familiarity with FDA regulations.

Responsibilities

• Support GMP operations on the manufacturing floor with QA oversight and guidance.
• Review SOPs, batch records, test methods, and logbooks for cGMP compliance.
• Write and approve SOPs, Master Batch Records, and CAPAs; ensure disposition of materials.

Skills

Leadership

QA operations

Documentation review

Regulatory compliance

Problem solving

Education

Bachelor’s degree

High school diploma

Job description

Lonza is seeking an experienced QA professional to support GMP operations on the manufacturing floor, providing guidance and performing documentation reviews to ensure cGMP compliance. The role involves writing and approving SOPs and batch records, and guiding CAPA processes to prevent deviations.

Ideal candidates will have a Bachelor’s degree, 5+ years in QA/manufacturing, and 1–2 years of leadership experience in pharma or biotech settings, with a commitment to safety and quality on site.