QA Team Lead - GMP Compliance & Process Improvement

Lonza Group Ltd.; Tampa (FL); In loco; USD 90.000 - 120.000; Tempo pieno

Descrizione del lavoro

Lonza Group Ltd. in Tampa, FL is seeking a Quality Assurance Lead to guide QA Operations on the GMP manufacturing and packaging floor.

The role includes reviewing SOPs, batch records, test methods, and logbooks, ensuring compliance with cGMP and FDA regulations. You will lead and develop a QA team, assess deviations, participate in investigations, and implement preventive actions, with a focus on product quality and safety in pharma/biotech contexts.

Competenze

• High school diploma or Bachelor's degree; 5+ years experience preferred.
• 1-2 years leadership experience.
• Experience in manufacturing operations, laboratory operations and/or QA, preferably pharma or biotech.

Mansioni

• Ensure QA Operations personnel engage on GMP floor, provide guidance and perform QA activities.
• Review SOPs, batch records, test methods and logbooks for cGMP compliance.
• Review raw materials, work orders, validation and MSAT reports as needed.
• Independently write SOPs or associated documentation.
• Independently approve SOPs, Master Batch Records, customer audits and CAPA.
• Ensure QA activities comply with SOPs, cGMP standards and FDA regulations.
• Dispositional authority for raw materials and finished products.
• Assess impact of deviations during lot release and investigations.
• Lead, train, develop, and retain QA Operations personnel.

Conoscenze

QA Leadership

GMP Compliance

SOP Review

Documentation Review

Team Training

Risk Assessments

Formazione

Bachelor's degree

Descrizione del lavoro

Lonza Group Ltd. in Tampa, FL is seeking a Quality Assurance Lead to guide QA Operations on the GMP manufacturing and packaging floor.

The role includes reviewing SOPs, batch records, test methods, and logbooks, ensuring compliance with cGMP and FDA regulations. You will lead and develop a QA team, assess deviations, participate in investigations, and implement preventive actions, with a focus on product quality and safety in pharma/biotech contexts.