Drug Product QA Specialist - Flexible Work Options

Amgen Inc. (IR); Thousand Oaks (CA); Sur place; USD 104 000 - 141 000; Plein temps

Avantages offerts par ce poste

Stock-based incentives

Retirement plan

Medical, dental and vision coverage

Discretionary annual bonus

Résumé du poste

Amgen’s Thousand Oaks site seeks a Drug Product Quality Assurance Specialist to provide quality oversight for aseptic manufacturing and inspection areas. You will ensure compliance with cGMP, quality systems, and regulatory expectations while partnering with Manufacturing, Facilities & Engineering, QC, and cross-functional teams.

The role emphasizes CAPA, deviations, change controls, and document control with exposure to audits and regulatory inspections.

Qualifications

• Doctorate degree OR Master’s degree with 2 years of QA experience.
• Bachelor’s degree with 4 years QA experience.
• Associate’s degree with 8 years QA experience.
• High school diploma / GED with 10 years QA experience.

Responsabilités

• Provide Quality oversight to aseptic drug product manufacturing and inspection areas.
• Collaborate with Manufacturing, Facilities & Engineering, and QC to ensure regulatory compliance.
• Review and approve controlled documents and change controls.
• Participate in internal and external audits and inspections.
• Drive CAPA programs, root cause analysis, and risk assessments.

Connaissances

Quality Assurance

GMP

CAPA

Change Control

Root cause analysis

Documentation

Audits

Cross-functional collaboration

Formation

Doctorate/PhD or Master’s + 2 years of QA experience

Bachelor’s degree + 4 years QA experience

Associate’s degree + 8 years QA experience

High school/GED + 10 years QA experience

Description du poste

Amgen’s Thousand Oaks site seeks a Drug Product Quality Assurance Specialist to provide quality oversight for aseptic manufacturing and inspection areas. You will ensure compliance with cGMP, quality systems, and regulatory expectations while partnering with Manufacturing, Facilities & Engineering, QC, and cross-functional teams.

The role emphasizes CAPA, deviations, change controls, and document control with exposure to audits and regulatory inspections.