Amgen Senior Associate QC Systems in Dublin, Ireland
Senior Associate QC Systems - FTE
Amgen Dun Laoghaire - Dublin
This job specification outlines the general responsibilities associated with the role of Senior Associate for QC Systems at Amgen Dun Laoghaire which includes:
Administration and Technical Support in conjunction with the BPO for the QC Enterprise systems LIMS/ LMES/ CIMS/ Empower.
Leading, coordinating, contributing to and undertaking activities pertaining to Quality Control Deviations, Corrective/ Preventive Actions, Analytical Results Assessments and Change Control records.
The role provides technical expertise with a focus on Compliance, Continuous Improvement while implementing a Lean Culture and Right First Time (RFT). The role also represents the QC unit by liaising with internal and external customers. The role may involve carrying out additional work functions that are not described in this specification but are associated with the role.
QC Enterprise Systems support
Work with site business owners to provide laboratory business administration, implementation and technical support services for SM-LIMS, Accelrys Smartlab (LMES) and Accelrys CIMS (Inventory Management), Empower.
Build, develop and maintain LIMS templates.
Evaluate new or revised eProcedures in conjunction with lab SMEs.
Provide support for LMES eProcedure implementation e.g. CIMS updates and SOP updates.
Provide end user support for LIMS.
Review and Approval of Quality Documentation e.g. Sample Plans FORMs and Environmental Monitoring sample plans.
Contribute to Computer System Validation activities within the QC laboratory.
Develop and deliver training for laboratory LIMS/LMES/CIMS requirements in adherence to Amgen requirements, SOPs, Standards, GAMP5, Annex 11, PIC/s and 21 CFR part 11 for all laboratory systems.
Identify, manage and implement continuous improvement projects related to laboratory applications and improving user experience.
Work with site business owners to evaluate system practices for compliance and ensure the system’s application user operations procedures are accurate and effective for the application.
Partner with the global Master Data Group as needed.
Provide input on global level topics related to LIMS/ LMES/CIMS/ Empower.
Provide Instructor led training for QC laboratory applications.
QC Deviations and Change Control support
All activities within Amgen’s Quality System associated with QC Deviations, CAPA records, Analytical Results Assessments and Change Control.
Report writing for investigations.
Lead, contribute to, oversee, run and participate in Root Cause Analysis, implementing improvements and Corrective Actions.
Trend analysis of Deviations relating to QC.
Ensure investigations constantly reflect current requirements and expectations.
Participate in cross functional teams with colleagues from other departments to assess, communicate and manage information and performance via scorecards and meetings.
Ensure timely completion of QC Deviations, CAPAs and Change Controls utilizing the appropriate procedures and Quality Management Tracking System (QMTS).
Ensure timely completion of each stage of the Analytical Results Assessments in line with the Quality Control Out of Specification and Unexpected Results procedure(s).
Ensure flow of communication to stakeholders.
Develop and maintain quality systems within QC to ensure ongoing compliance with cGLP.
Audit and Inspection preparation and participation.
Lead continuous improvement activities to achieve standards of operational excellence for Amgen.
Perform tasks and participate on project teams assigned to assist in the timely completion of activities associated with the attainment of group, departmental, team and corporate goals.
Apply expertise and critical thinking to independently resolve issues.
Provide technical guidance.
Be responsible for specific programs and/or projects. Key Competencies:
Apply analytical thinking to evaluate and interpret complex situations/problems using multiple sources of information.
Anticipate and prevent potential problems.
Excellent verbal and written communication skills including technical writing, presentation and facilitation skills.
Strong ability to lead teams and effectively utilize team resources.
Ability to evaluate complex compliance issues.
Ability to work in a fast paced environment with changing priorities.
Excellent Organisational Skills and Time Management.
Ability to work under minimal supervision.
Ability to identify and manage competing priorities.
Skills in the areas of teamwork, flexibility, coaching and motivating.
Knowledge and Experience:
Hold a third level qualification in a Science related discipline.
Minimum 4 years experience in a Biotechnology/ Pharmaceutical/ GMP Environment.
Familiar with (or can learn) new laboratory information systems and can self-teach technical topics.
Knowledge of lab operations, analytical lab techniques, commercialization, and cGMP.
Knowledge on Data Integrity Assessments (DIA) for computerised systems and execution of CFR 21 Part 11 for computerised systems.
Experience in interacting with regulatory agencies including written responses.
Experience as a user (as a minimum) for LIMS/LMES/CIMS/ Empower.
Experience with Deviations and Laboratory investigations, CAPAs.
Experience in leading Root Cause Analysis would be advantageous.