Career Category

Job Description

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 SOPs
• Observe and provide real-time Quality oversight and support for manufacturing on the floor. (Formulation & Aseptic Filling or Inspection depending on the unit of operation).
• Perform quality manual visual inspections of vials and syringes.

• Participates in customer complaint investigations.
• Perform In-Process checks as required.
• Provide Quality support for triage and investigation of all classes of deviation events
• Review and approval of Deviations and CAPAs for closure ensuring compliance with appropriate documentation, whilst ensuring that CAPA actions address root cause and implementation plan dates are achievable

• 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
• Experience working with combination products or devices in packaging-related or complaint-handling activities (Applicable to roles in the Inspection & Packaging Team but not the Formulation & Aseptic Filling Team).

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