Amgen Specialist QA in Dublin, Ireland
Quality Assurance Specialist (Level 05) Amgen Dun Laoghaire - Dublin
The Quality Assurance (QA) Specialist will be an active member of the ADL QA team. The QA Specialist will be assigned to the IQA Quality functional area, which is responsible for the inspection and release of primary packaging components, in addition to the analysis of Defect Data from Incoming and Finished Product Inspection. The QA Specialist will report to a QA Senior Manager.
Additional responsibilities commensurate with QA Specialist level may extended in line with business requirements, these responsibilities may expand or otherwise include additional areas of responsibility which are not described in this specification but are associated with the IQA role.
Incoming Quality Assurance Specialist Key Responsibilities
Provide Subject Matter Expertise in relation to the testing of primary and packaging components for use in the manufacture of aseptic products.
Approve IQA Incoming test results.
Manage the introduction of new techniques and equipment to QA Incoming, including method transfers, and validations
Write protocols and perform validation and equipment qualification/verification.
Assume ownership and/or oversight of change control and NC/CAPA records; ensuring the scope of record is clear and implementation activities are robust and timely.
Plan to perform routine analyses with efficiency and accuracy
Compile and Analyse Metrics related to testing and disposition times for IQA
Analyse Defect Data from Incoming and Finished Product Inspection.
Generate Acceptance Sampling Plans to Justify acceptability of products.
Compile Technical Reports.
Write, review and approve Standard Operating Procedures in accordance with Amgen Policies.
Participate in customer complaint investigations with suppliers of components and packaging.
Provide training and advice to staff in relation to testing of components.
Actively participate in audits and their preparation.
Evaluate practices for compliance and operational excellence improvement on a continuous basis.
Perform all activities in compliance with Amgen safety standards and SOPs
Ensure all GMP compliance training is up to date before performing GMP activities and participate in training of new colleagues
Perform all tasks with due care and attention and in accordance with Good Manufacturing Practices and Amgen requirements, policies and procedures.
Act as a designee for the Supplier Quality Management role and Sr. Management role within the group
University degree. Engineering or Science related discipline preferred.
Relevant experience (8yrs +) 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 and Experience
Excellent written and verbal communication skills
Experience working with dynamic cross-functional teams and proven abilities in decision making
Project management or 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
Detailed Knowledge of applicable Regulatory requirements. Experience with Regulatory inspections.
Experience working in aseptic operations, protein formulation, vial and syringe filling.
Use of Minitab, Excel and Smart Sheets