JOB DESCRIPTION:

The Sr. Associate in Quality Assurance (QA) will be an active member of the QA team and will be assigned to the IQA Quality functional area, which is responsible for the inspection and release of primary packaging components. The Sr. Associate in Quality Assurance will report to a QA Senior Manager and will serve as Quality point of contact for Incoming Inspection of Primary and packaging components.
The site is focused on continuous improvement of all work processes and practices, therefore in addition to routine Quality Assurance duties, IQA Snr. Associates may be asked to carry out additional work functions to support site continuous improvement activities.

Incoming Quality Assurance Sr. Associate Key Responsibilities

• Testing of primary and secondary components for use in the manufacture of aseptic products.
• Sampling of Excipients and Drug Substance under Grade C conditions.
• Review/approve documentation associated with component testing in preparation for QA Specialist or Qualified Person disposition activities
• Compiling, Review and approval of minor NC and CAPAs for closure ensuring compliance with appropriate documentation, whilst ensuring that CAPA actions address root cause and implementation plan dates are achievable
• Provide training and advice to staff in relation to testing of components and packaging.
• Actively participate in audits and their preparation.
• Review cGMP records (e.g., WO, JP, GDMS, NC, CAPA, protocols, reports, SOP, etc.) ensuring compliance with appropriate documentation
• Write, review and approve Standard Operating Procedures in accordance with Amgen Policies.
• Perform all activities in compliance with Amgen safety standards and SOPs
• Support continuous improvement and Operational Excellence initiatives
• Any other tasks/projects assigned as per manager’s request.

Basic Qualifications & Experience:

• Must Pass Eye-Tests required for Visual Inspection
• University degree. Engineering or Science related discipline preferred.
• Relevant experience (4 yrs. +) 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 / Non-Conformance /Deviation investigations
• Experience working in aseptic operations, protein formulation, vial and syringe filling.

• Testing of primary and secondary components for use in the manufacture of aseptic products.
• Sampling of Excipients and Drug Substance under Grade C conditions.
• Review/approve documentation associated with component testing in preparation for QA Specialist or Qualified Person disposition activities
• Compiling, Review and approval of minor NC and CAPAs for closure ensuring compliance with appropriate documentation, whilst ensuring that CAPA actions address root cause and implementation plan dates are achievable
• Provide training and advice to staff in relation to testing of components and packaging.
• Actively participate in audits and their preparation.
• Review cGMP records (e.g., WO, JP, GDMS, NC, CAPA, protocols, reports, SOP, etc.) ensuring compliance with appropriate documentation
• Write, review and approve Standard Operating Procedures in accordance with Amgen Policies.
• Perform all activities in compliance with Amgen safety standards and SOPs
• Support continuous improvement and Operational Excellence initiatives
• Any other tasks/projects assigned as per manager’s request