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Diagnostic Technologist

AbbottLongford

JOB DESCRIPTION

About Abbott

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 109,000 colleagues serve people in more than 160 countries.

Abbott serves the Irish market with a diverse range of healthcare products including diagnostics, medical devices and nutritionals products. In Ireland, Abbott employs over 4,000 people across nine sites. We have six manufacturing facilities located in Clonmel, Cootehill, Donegal, Longford and Sligo and a third-party manufacturing management operation in Sligo. Abbott has commercial, support operations and shared services in Dublin and Galway. We have been operating in Ireland since 1946.

Abbott Ireland Diagnostic Division – Longford:
Abbott established a diagnostics manufacturing facility in Sligo in 1994 to manufacture blood-screening products and reagents.

In 2004, Abbott’s operations in Ireland expanded with the opening of a second facility in Longford. The plant was first occupied in December 2004, and the first product (Architect® TSH) was launched in December of 2005.

The Longford facility plays a key role in helping Abbott to meet the increasing global demand for diagnostic testing in areas such as infectious disease, cancer, thyroid and cardiovascular diseases.

Abbott in Longford manufactures 18 diagnostic reagent products for thyroid function, fertility, and pregnancy, cardiology, renal and metabolic. Our products are manufactured to the highest standards of quality and are regulated by bodies such as the U.S. Food and Drug Administration and the International Organization for Standardization (ISO).

PURPOSE OF THE JOB:

  • To ensure the plant meets its customer service, financial, inventory management, quality and safety goals through the timely execution of the Production Schedule.

  • To carry out all activities assigned to ensure that production targets in terms of quality, quantity, volume are attained.

MAJOR RESPONSIBILITIES

  • Perform all duties as assigned by Team Leader.

  • Carry out operations in the manufacturing area including:

    • Manufacturing Processes

    • Documentation Practices

    • Computer applications e.g. LDRS, DMS, LIMS, ETMS & ERP

    • Environmental Monitoring Control Sampling

  • levels, per plan requirements.

  • Complete and comply with all relevant documentation.

  • Adhere to all GMP and GLP requirements.

  • Ensure safe work practices and behavior on the job at all times.

  • Ensure that activities are completed within budget e.g. waste

  • Carry out training of new employees as appropriate.

  • Support continuous improvement by assisting in and become involved in

  • Cost-saving ideas & projects.

  • Assist in compiling information for annual budgets.

  • Maintain adequate stocks of operating supplies and consumables within the laboratory.

  • Revising Procedures and other documentation as appropriate.

  • Use of computer applications as appropriate.

  • Assist in executing validation protocols.

  • Maintain ETMS TO DO LIST.

  • Conduct business in a manner that will protect human health, safety and the environment by complying with all applicable EHS laws, as well as the Abbott Global & Technical Standards.

Function Specific Responsibilities

Concentrates:

  • Manufacturing of Microparticle and Conjugate components.

  • Use of Systems such as AMP’s, MAGSEP, FPLC, Spectrophotometer

  • Use of equipment such as stir plates, roller mixers, end over end rotators, pumps and filters.

  • Chmeical Dispense of material required for manufacturing.

  • Adhere to GMP requirements of Class 8 and Class 5 areas and aseptic techniques.

  • Perform line clearance as required.

  • Adhere to manufacturing formula instruction and procedural requirements.

  • Support of any manufacturing activites required by AIDD.

Solutions:

  • Manufacturing of Bulk Calibrator, Control, Reagents, Stocks, Buffers and Diluents.

  • Large scale batch tank manufacture and smaller scale carboy manufacture.

  • Use of equipment such as tanks, stir plates, roller mixers, end over end rotators, pumps, filters and equipments.

  • Chemical Dispense of material required for manufacturing.

  • Adhere to GMP requirements of Class 8 and Class 5 areas and aseptic techniques.

  • Peform line clearnace as required.

  • Ahdere to manufacturing formula instruction and procedural requirements.

  • Support of any manufacturing activites required by AIDD.

Testing:

  • In process testing of Bulk Solutions manufactured at AIDD Longford as per Standard Control Procedure.

  • Customer Release Testing of filled vials as per Standard Control Procedure.

  • Peform routine maintenance on an operation of ADD analysers eg. Architect and Alinity.

  • Execution of In Process Testing through Laboratory Information Management System (LIMS).

  • Execution of Testing as required through Instrument Customer Interface as required.

  • Non platform testing of AIDD Longford manufactured products including but not limited to HPLC, Lot Uniformity, % solids, LCMS.

  • Test Control Procedure Verificaton of generated results through the LIMS system and review and verification of all test results generated at AIDD Longford.

  • Initiation, authoring and approval of Laboratory Investigation Reports and Change Requests for instrument flagged errors.

  • Execution and Verification of On Market Stability test points as per Standard Control procedure and procedural requirements.

  • Execution of Developmental Stability protocols.

  • Execution of Complaints and Equas testing requested by the PQA group.

  • Support of any testing activities required by AIDD.

EDUCATION & COMPETENCIES:

  • The following level of education provides a necessary foundation for this Job function:

  • Minimum Leaving Certificate or equivalent plus Certificate in a relevant discipline, as this foundation will provide a basic understanding of the scientific principles required to understand the manufacturing processes and the skills required to record and analyze scientific data.

  • The following experience provides a necessary foundation for this Job function:

  • Previous experience in a scientific manufacturing environment is desirable but not essential. This experience would provide a foundation in the areas of Good Manufacturing Practice (GMP) and Good Laboratory Practice (GLP).

  • The Diagnostic Technologist must be trained on the relevant procedures and processes before taking responsibility for a manufacturing task. Failure to follow the relevant procedures could result in manufacturing failures or customer complaints and product recalls with the associated financial losses.

  • A trained individual is given authority and responsibility to carry out duties without close supervision.

  • Formal goals are reviewed on a regular basis and formal performance reviews are carried out.

Connect with us at www.abbott.com or https://www.ie.abbott/, on LinkedIn at www.linkedin.com/company/abbott-/, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews.

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