Sr. Associate QA

Responsibilities

• Provide real-time Quality oversight and support for manufacturing operations, including Formulation, Aseptic Filling, Inspection, or Packaging.
• Perform quality manual visual inspections of vials and syringes.
• Support the triage and investigation of all classes of deviation events.
• Review and approve deviations for closure to ensure compliance with documentation standards.
• Review and approve production batch records and associated documentation for Qualified Person disposition.
• Perform in-process checks and participate in customer complaint investigations.
• Write, review, and approve Standard Operating Procedures (SOPs) in accordance with company policies.
• Support continuous improvement and Operational Excellence initiatives.

Requirements

• University degree in an Engineering or Science related discipline.
• 4+ years of experience working in the pharmaceutical or biotechnology industry.
• Proven experience with deviation investigations and Root Cause Analysis (RCA).
• Ability to work in a 24/7 shift-based environment to support manufacturing operations.

Preferred Qualifications

• Excellent written and verbal communication skills.
• Experience working with dynamic cross-functional teams and strong decision-making abilities.
• Experience with combination products or devices in packaging or complaint-handling activities.
• Knowledge of applicable regulatory requirements and the ability to evaluate compliance issues.
• Background in Operational Excellence.

About the Company

Amgen is a leading biotechnology pioneer committed to unlocking the potential of biology for patients suffering from serious illnesses. By discovering, developing, and manufacturing innovative human therapeutics, Amgen leverages advanced human genetics and biologics expertise to improve health outcomes and dramatically improve people's lives worldwide.