Quality Assurance Specialist - GMP & QA Oversight

Aerogen Pharma; Foster City (CA); Presencial; USD 88.000 - 105.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Medical, Dental, Vision

401k

Paid Time Off 15-20 days

Employee Assistance Program

Short-Term Disability

FMLA Benefits

Descripción de la vacante

Aerogen Pharma in Foster City, CA is seeking a Quality Specialist to support Quality Operations through the oversight of Manufacturing, Packaging, and Labeling batch records, product review and approvals, and supplier management. The role also supports continual process improvement for the Quality Management System.

The ideal candidate has a Bachelor’s degree in life sciences and 3+ years in GMP QA, with experience reviewing batch records and overseeing CMOs.

Formación

• Bachelor’s degree in pharmacy, chemistry, biochemistry, microbiology, engineering, life sciences, or a related discipline.
• 3+ years in pharmaceutical/biotech or similarly regulated industry with 2+ years in GMP QA or manufacturing.
• Direct experience reviewing batch records and product disposition strongly preferred.
• Experience overseeing CMOs or suppliers is preferred in outsourced GMP settings.
• Familiarity with 21 CFR Parts 4, 210/211, 600/601, 820; ISO 13485/14971; data-integrity expectations.

Responsabilidades

• Batch Record Review across manufacturing, packaging and labeling.
• Review data and support QA documentation for lot disposition.
• Support internal/external audits and regulatory inspections.
• Investigate deviations, CAPAs, change controls and IRs.
• Coordinate with CMOs and suppliers to address quality issues.

Conocimientos

GMP Knowledge

QA Oversight

cGMP Documentation

ALCOA Data Integrity

Regulatory Audits

Educación

Bachelor’s degree in life sciences or related

Herramientas

Veeva

TrackWise

MasterControl

SAP

Oracle

Descripción del empleo

Aerogen Pharma in Foster City, CA is seeking a Quality Specialist to support Quality Operations through the oversight of Manufacturing, Packaging, and Labeling batch records, product review and approvals, and supplier management. The role also supports continual process improvement for the Quality Management System.

The ideal candidate has a Bachelor’s degree in life sciences and 3+ years in GMP QA, with experience reviewing batch records and overseeing CMOs.