Manufacturing QA & Compliance Specialist II

F. Hoffmann-La Roche AG; Oceanside (CA); Vor Ort; USD 67.000 - 125.000; Vollzeit

Benefits dieser Stelle

Discretionary annual bonus

Zusammenfassung

Genentech is seeking a Manufacturing Quality Assurance (MQA) Associate II to provide QA support ensuring compliance with GMP and health authority regulations in our Oceanside facility. The role focuses on manufacturing documentation, deviations, and change control within a cross-functional team.

You will review batch records, support regulatory inspections, and contribute to process improvements while collaborating with multiple departments to resolve quality issues and ensure product quality

Qualifikationen

• Bachelor's degree in Biology or Biochemistry preferred.
• Minimum 4 years in pharmaceutical manufacturing QA.
• Solid knowledge of GMPs, SOPs, and quality systems.
• Experience with deviations and change control a plus.

Aufgaben

• Oversee manufacturing documentation and deviations.
• Review batch records and batch reports.
• Participate in cross-functional QA meetings for process improvement.
• Provide QA support for raw material, in-process, bulk and final product issues.
• Support FDA/Regulatory and internal inspection activities.
• Write and revise SOPs including Change Control.
• Assess and approve changes in Change Control.

Kenntnisse

GMP knowledge

SOP proficiency

Quality systems understanding

Validation principles

Strong communication

Cross-functional collaboration

Computer-based systems

Ausbildung

Bachelor's degree in Biology or Biochemistry

Tools

Computer-based systems

Jobbeschreibung

Genentech is seeking a Manufacturing Quality Assurance (MQA) Associate II to provide QA support ensuring compliance with GMP and health authority regulations in our Oceanside facility. The role focuses on manufacturing documentation, deviations, and change control within a cross-functional team.

You will review batch records, support regulatory inspections, and contribute to process improvements while collaborating with multiple departments to resolve quality issues and ensure product quality