Sr. Associate IQA - 16/5 Shift

Amgen Inc. (IR); Dublin; On-site; EUR 55,000 - 75,000; Full time

Job summary

Amgen Inc. (IR) in Ireland seeks a Senior Associate in Quality Assurance to support IQA activities, inspect and release primary packaging components, and serve as QA contact for incoming inspection. The role emphasizes continuous improvement and adherence to Amgen policies.

The position reports to a QA Manager and requires hands-on testing, documentation review, and cross-functional collaboration with suppliers and internal teams.

Qualifications

• Must pass eye-tests for visual inspection.
• University degree required; engineering or science preferred.
• 4+ years of relevant pharma/biotech experience.

Responsibilities

• Test primary and secondary components for use in aseptic manufacturing.
• Sample excipients and drug substance under Grade C conditions.
• Review/approve documentation for component testing for QA/QP disposition.
• Prepare and close minor NCs and CAPAs with root-cause analysis.
• Participate in supplier component customer complaint investigations.
• Provide training on testing of components and packaging.
• Assist in audits and audit preparation.
• Review and approve cGMP records and SOPs.
• Write/review/approve SOPs per Amgen policies.
• Ensure compliance with safety standards and SOPs.
• Contribute to continuous improvement and operational excellence initiatives.

Skills

Excellent communication

Cross-functional teamwork

Strong organizational skills

Problem solving

Quality mindset

Education

University degree

Engineering or Science discipline preferred

Job description

Career Category Quality 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.

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.

Salary Range 55,284.00 EUR - 74,796.00 EUR

Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. Amgen focuses on areas of high unmet medical need and leverages its biologics manufacturing expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential. For more information, visit www.amgen.com and follow us on www.twitter.com/amgen