Amgen Sr. Associate PQA (Shift) in Dublin, Ireland
QA Sr. Associate PQA – Shift Role
The Quality Assurance (QA) Senior Associate will typically report to a Snr 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. A variety of shift patterns may be required to support operations, including but not limited to day shift, 16/5 shift, 24/5 shift and 24/7 shift. Weekend work may also be required.
The Plant QA team structure is split into 2 groups with one group responsible for oversight of aseptic manufacturing (Formulation and Fill) and another group responsible for oversight of the Inspection and Packaging operation. Currently there are available roles in both groups.
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 & Packaging depending on the unit of operation)
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
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.