Amgen Snr Associate - Plant Quality Assurance - 24/7 Shift in Dublin, Ireland
Sr. Associate PQA – Shift Role
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.
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
If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.
Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.
As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.