Sr. Associate IQA - 16 / 5 Shift

Amgen SA; Dún Laoghaire; On-site; EUR 60,000 - 90,000; Full time

Job summary

Amgen in Ireland seeks a Sr. Associate in Quality Assurance to join the IQA function, focusing on inspection and release of primary packaging components. The role reports to a QA Manager and acts as the QA contact for Incoming Inspection of primary and packaging components.

The site emphasizes continuous improvement; additional tasks may be assigned to support site CI activities while ensuring compliance with Amgen policies and safety standards.

Qualifications

• Bachelor's level degree in engineering or science required.
• Minimum 4 years in pharma/biotech, or equivalent.
• Eye-tests for visual inspection must pass.

Responsibilities

• Test primary and secondary components for aseptic products.
• Sample Excipients and Drug Substance under Grade C.
• Review and approve testing documentation for QA disposition.
• Compile and close minor NC and CAPA with root-cause focus.
• Participate in supplier/customer complaint investigations.
• Provide training on component and packaging testing.
• Participate in audits and audit preparations.
• Review and approve cGMP records (WO, JP, GDMS, NC, CAPA, SOPs).
• Write, review and approve SOPs per Amgen policies.
• Adhere to Amgen safety standards and SOPs.
• Support continuous improvement initiatives.

Skills

Eye-tests

Cross-functional teamwork

Communication skills

Problem solving

Organizational skills

Root cause analysis

Aseptic operations

Education

University degree in Engineering or Science

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 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
• Participates in customer complaint investigations with suppliers of components.
• Provide training and advice to staff in relation to testing of components and packaging.
• Actively participate in audits and their preparation.
• Review and approve 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.