Amgen Sr Associate QA in Dun Laoghaire, Ireland
The Plant Quality Assurance (PQA) Snr Associate will typically report to a QA Manager and is a core member of the site Quality Assurance team. The PQA Snr Associate will serve as Quality point of contact for manufacturing operations.
The site is focused on continuous improvement of all work processes and practices, therefore in addition to routine Quality Assurance duties, PQA 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 manufacturing operations, including but not limited to day shift. Overtime may also be required.
Perform all activities in compliance with Amgen safety standards and SOPs
Write, review and approve Standard Operating Procedures in accordance with Amgen Policies.
Provide Quality support for triage and investigation of all classes of deviation events
Review and approval of Class 1 deviations 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.
Provides training and advice to staff in order for them to perform their desired functions.
Observe and provide real-time quality oversight, and support for production unit operations, extending to formulation, vial and Syringe Fill Finish related activities, including observation and provision of direction during media fills and assessment of aseptic interventions.
Review/approve production batch records, and associated documentation in preparation for Qualified Person disposition activities.
Review and approve cGMP records (e.g., NC, CAPA, protocols, reports, SOP, etc.) ensuring compliance with appropriate documentation
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 (2 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.
Knowledge of applicable Regulatory requirements, and ability to evaluate compliance issues
Operational Excellence experience