Quality Specialist Micro Laboratory

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 114,000 colleagues serve people in more than 160 countries.

Abbott in Ireland

Abbott has been operating in Ireland since 1946 and serves the Irish market with a diverse range of healthcare products including diagnostics, diabetes care, medical devices and nutritional products. In Ireland, Abbott currently employs about 6,000 people across ten sites located in Dublin, Donegal, Clonmel, Cootehill, Galway, Kilkenny, Longford and Sligo.

Abbott Ireland Nutrition Division Cootehill Cavan

Abbott Nutrition produces a range of infant formulae in all pack sizes under the brand name “Similac”. To complement the range of “Similac” infant formulae, the facility also manufactures a range of follow on formulae under the brand name of “Gain”. The essential ingredient is liquid skim milk and this is combined with carbohydrate, vegetable oils, vitamins and minerals. The product is blended, pasteurised, dried and packaged at the site and once packaged, is distributed to Europe, South East Asia, the Middle East, Latin America and Canada.

Established in 1975, Abbott Nutrition in Ireland is the largest powder manufacturing facility for the production of infant formulae within the Abbott Corporation worldwide.  Approximately 1,000 dairy farms in Ireland and Northern Ireland supply quality milk to the Cootehill facility which processes 500,000 litres per day. This secure supply together with Ireland’s reputation as a green, clean environment is of significant strategic importance to Abbott Nutrition.

Primary Function / Goals / Objectives

• This function has the responsibility for reviewing all Environmental Monitoring Program (EMP) SOPs for any job task they may carry out and ensure they fully understand and adhere to all SOPs.

• This role will actively participate in the plant auditing programme especially in the area of EMP, cGMP and microbiological control.  

• This Job function may change where updates are made to cGMP, EHS, Technical / New Equipment, and Quality Processes/SOP’s.

• This list of responsibilities may change depending on plant needs and employees are expected to be adaptable and flexible where this need arises. 

• This function will cover Laboratory Supervisor duties as the need arises.

• Follow all Environmental, Health and Safety Rules and Regulations within the plant.

• Report any current or potential hazards to your manager immediately.

• The Microbiology Laboratory Specialist must always wear the correct Personal Protective Equipment (P.P.E.)  for the work they are carrying out in order to protect themselves from biological hazards and general laboratory hazards.

Major Responsibilities

• The Microbiology Laboratory Specialist will oversee the timely and compliant completion of all EMP results/trending reports.

• Allocation, scheduling and managing laboratory resources for group's activities.

• Coordinating and prioritizing (internal and third-party laboratory) testing to ensure testing is completed on time to meet release metrics and market requirements.

• Review and approval of all laboratory EMP paperwork including audit trails and authorising test results on LIMs.

• Support in Micro Laboratory Technician training programmes in relation to EMP.

• Attending Daily Process meetings and maintaining good communications with the Process Department.

• Assist other departments in identification of products and processes that may help overall hygiene improvements.

• Co-ordination, maintenance and reporting of plant environmental programme to management.

• Continuous research activities including contact with regulatory, Analytical & Research Services and Division Microbiology SME’s.

• This function is responsible for developing and maintaining the plant swabbing programme.

• This role will be responsible for trending results and preparing and reporting EMP metrics to the plant. 

• Maintain a good level of housekeeping and good manufacturing practices within the laboratory and the completion of weekly GMP audits.

• Maintain a high standard of Good Laboratory Practice and Safety Compliance, be audit ready and identify areas for improvement. 

• Preparation and implementation of QA SOPs and test methods. Ensuring adherence and making recommendations to quality system improvements. Completion of periodic reviews of Policies and Procedures.

• This function will support laboratory projects in relation to test method transfers, new equipment introduction and validation and data integrity initiatives.

• The function will manage LIRs (Laboratory Investigation Reports) and support all laboratory related QRs / investigations to reach root cause and identify corrective/ preventive actions

Education Required

• Degree in Microbiology or related Scientific discipline.

Knowledge & Skills

• Three plus years’ experience in the food, pharmaceutical, biotech or microbiological laboratory industries is desirable.

• Full understanding of GMP/ FDA requirements,

• Strong understanding of compliance and quality standards.

• Very good understanding of the microbiological techniques & methods used.

• Excellent interpersonal and computer skills and the ability to work as an effective member of a high-performance team.

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