Amgen Specialist Quality Control in Dublin, Ireland
This job specification outlines the general responsibilities associated with the role of the QC LMES/CIMS/EMpower with LIMS Specialist at Amgen Dun Laoghaire. This role will be responsible for leading, coordinating, facilitating, and undertaking activities pertaining to LMES/CIMS/EMpower and QC IS systems, without direct supervision, acting as a role model for other lab colleagues. The role provides technical expertise with a focus on Compliance, Continuous Improvement, a Lean Culture and Right First Time (RFT). The role also represents the QC unit by liaising with internal and external network customers. This role partners closely with the QC LIMS Specialist including some shared activities. Additionally, the role may involve carrying out additional work functions that are not described in this specification but are associated with their role.
Quality Control Business Owner and Laboratory Administrator for LMES ( Accelrys LES, Accelrys IM), CIMS (Accelrys CIMS) and Waters Empower CDS.
Acts as delegate for Thermo LIMS business owner.
Deliver effective software support services to QC functions and liaises with Global teams and local IS.
Manage and implement projects to maintain, develop and support lean laboratory practices such as review by exception, paperless lab systems SM- LIMS, Accelrys Smartlab (LES) and Accelrys CIMS (Inventory Management).
Responsible for Computer System Validation within the QC laboratory to allow integration of laboratory instruments and systems to Smartlab (LMES).
Manage the implementation and/or upgrade of laboratory Enterprise systems.
Facilitate IT projects within Amgen such as network upgrades project, disaster recovery and migration activities.
Develop Accelrys LES electronic methods (eProcedures) using Method Builder application and instrument parsing techniques to allow seamless integration and quick deployment of Accelrys LES.
Management of the introduction of new eProcedures and their qualification.
Develop and troubleshoot laboratory methods in LMES using Smartlab Method Builder and instrument parsing techniques.
Templating execution and approval in LIMS including Sample Plan review.
Develop training documentation and SOP’s for computer system applications and computer system validation documentation in adherence to Amgen requirements, SOP’s, standards, GAMP5, Annex 11, PIC/s and 21 CFR part 11 for all laboratory systems.
Monitoring of Computer System Validation status and System Health. E.g. System Periodic Review activities
Develop and continuously improve training documentation and SOP’s for laboratory IS requirements and act as trainer for Laboratory IS systems.
Develop computer system validation documentation in adherence to GAMP5, Annex 11, PIC/s and 21 CFR part 11 for all laboratory systems.
Champion for Data Integrity Assessments (DIA) for computerised systems.
Supports audits and inspections in relation to QC IT systems.
Knowledge and Experience:
Hold a third level qualification in Science related discipline or IT/IS role.
Have minimum 8 years' experience in Pharmaceutical or Biopharmaceutical Industry.
User Knowledge and experience with the following: Accelrys LES, Accelrys IM, Thermo LIMS and Waters Empower CDS is preferable
Knowledge and experience with eProcedure Qualification would be advantageous
Knowledge of Lab Operations, Analytical Lab Techniques, Commercialization, and cGMP and NPI advantageous
Keen interest is troubleshooting lab system issues and Continuous Improvement
Key Competencies for the role include planning, organisation, problem solving, communication, teamwork, flexibility, coaching and motivating.
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.