QA Operations Lead, GMP & Compliance

Lonza Biologics, Inc.; Tampa (FL); Sur place; Confidential; Plein temps

Résumé du poste

Lonza Biologics, Inc. in Tampa, FL is seeking a Quality Assurance Lead to support GMP manufacturing and packaging operations on a 12-hour rotating day shift. The role focuses on QA activities, documentation review, and ensuring conformance to cGMP standards.

You will write and approve SOPs, Master Batch Records, CAPAs, and lead a QA Operations team while upholding FDA regulations and safety requirements.

Qualifications

• Bachelor’s degree preferred; high school diploma acceptable with relevant experience.
• 5+ years of experience in QA leadership.
• Experience in manufacturing operations or QA, preferably pharma/biotech.

Responsabilités

• Ensure QA Operations personnel engage on the GMP floor and provide support and guidance.
• Review SOPs, batch records, test methods, and logbooks for cGMP compliance.
• Write and approve SOPs, Master Batch Records, customer audits and CAPA.
• Lead, train, manage and retain QA Operations personnel.
• Adhere to Safety and Sustainability requirements and report issues to management.

Connaissances

QA Leadership

GMP knowledge

FDA regulations

Documentation review

Formation

Bachelor's degree

High school diploma

Description du poste

Lonza Biologics, Inc. in Tampa, FL is seeking a Quality Assurance Lead to support GMP manufacturing and packaging operations on a 12-hour rotating day shift. The role focuses on QA activities, documentation review, and ensuring conformance to cGMP standards.

You will write and approve SOPs, Master Batch Records, CAPAs, and lead a QA Operations team while upholding FDA regulations and safety requirements.