Amgen Jobs

QA Sr. Associate PQA – Shift Role

Overview:

The Quality Assurance (QA) Senior Associate will report to a QA Manager and is a core member of the site Quality Assurance team. The QA Snr Associate will serve as Quality point of contact for Plant Quality Assurance (PQA). The site is focused on continuous improvement of all work processes and practices, therefore in addition to routine Quality Assurance duties, QA Snr Associates may be asked to carry out additional work functions to support site continuous improvement activities. This is a 24/7 shift role required to support manufacturing operations.

The Plant QA team structure is one group responsible for oversight of aseptic manufacturing (Formulation and Fill) and for oversight of the Inspection and Packaging operation.

Key Responsibilities:

• Perform all activities in compliance with Amgen safety standards and standard operating procedures.

• Observe and provide real-time quality oversight and support for manufacturing on the floor.

• Perform purposeful presence on the floor audits.

• Perform manual visual inspection AQL audits of vials and syringes.

• Perform QA reserve sample inspections as part of the annual reserve inspection program and in support of customer complaint investigations

• Certification of defect panels.

• Provide quality support for triage and investigation of all classes of deviation events.

• Review/approve deviations for closure ensuring compliance with appropriate standards.

• Review/approve production batch records, and associated documentation in preparation for qualified person disposition activities.

• Provides training and advice to staff in order for them to perform their desired functions.

• Write, review and approve standard operating procedures in accordance with Amgen policies.

• Support continuous improvement and operational excellence initiatives

• Any other tasks/projects assigned as per manager’s request.

Basic Qualifications & Experience:

• University degree. Engineering or Science related discipline preferred.

• Relevant experience (4 years +) working in the pharmaceutical or biotechnology industry or other combination of experience and educational background that may otherwise satisfy the requirements of the role.

Preferred Qualifications & Experience:

• Excellent written and verbal communication skills

• Experience working with dynamic cross-functional teams and proven abilities in decision making

• Strong organizational skills, including ability to follow assignments through to completion

• Demonstrated ability in problem solving and experience in managing Root Cause Analysis / Deviation investigations

• Knowledge of applicable Regulatory requirements, and ability to evaluate compliance issues

• Operational Excellence experience