Associate Quality Assurance Specialist

Found in: beBee S IE - 3 weeks ago

Sligo, Ireland Abbott Laboratories Full time
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 5,000 people across ten 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 Sligo

Abbott Diagnostic's is a global leader of in vitro diagnostics with approximately 70,000 institutional customers in more than 100 countries. Our diagnostic products offer a broad range of innovative instrument systems and tests for hospitals, reference labs, blood banks, physician offices and clinics. Abbottâs diagnostic products offer customers automation, convenience, cost effectiveness and flexibility. Abbott has helped transform the practice of medical diagnosis from an art to a science, helping to create the modern diagnostics industry through the company's commitment to improving patient care and lowering overall costs. The history of Abbott Diagnostics is filled with examples of first-of-a-kind products and significant technological advancements.

Department Function/ Objective

To ensure that the Quality System of the AIDD Sligo Plant is in compliance with Division and site Quality System requirements.

Primary function Working as a member of Quality Department's Microbiology Team,  conduct microbiology/ quality-related activities to deliver consistent, high quality documents, services, products and processes

Environmental Health &Safety Ensure EHS standards are met and all EHS Procedures and guidelines are adhered to. Foster Safety Awareness in the plant and promote a culture of continuous improvement.

Reporting The position reports directly to a relevant Departmental Quality team/unit leader or Manager. If required there may be a dual reporting role reporting to both Quality and another area as required.

Supervisory/ Management Responsibility The position has no direct people management responsibility.

 

Major Duties and Responsibilities

⢠General Area: Budgets own time to carry out assigned duties that support business goals. Interacts constructively with employees, managers and crossfunctional peers. Completes compliant documentation and provides solutions to local problems of low scope and complexity. Supports project work and acts as process community member.

⢠Quality System Compliance: Maintains awareness of industry regulatory standards. Ensures compliance to site level policies and procedures by promptly reporting non-compliance issues to the department manager. Works effectively within the team.

⢠Risk Management: Applies basic Risk Management principles to work.

⢠EHS: Complete all activities in a safe manner ensuring that any potential safety issues and areas for improvement are highlighted to Manager. Ensure Environmental procedures e.g. recycling, waste minimization are adhered to and improvements made where possible.

Depending on Functional Area

⢠Design Control / Documentation & Change Control: Assist initiators of change control documentation, including change plans, design plans and change requests (as required) to aid in the implementation of change. Reviews and approves changes to QSR and DMR documentation as required. Initiates site Change Plan and Document Change Request activities (as required) for changes identified through Product / Process improvement,Transfer activities and/or Identified compliance issues. Coordinate and manage Change Plan and Document Change Requests through to closure, including tracking of identified deliverables and action items. Work in conjunction with relevant Document/ Process owners to identify and organize CFTs. Identifies needs.

⢠CAPA: Demonstrates good knowledge of the CAPA system and ensures compliance to all aspects as applicable

 

Leadership Activities May be required to lead cross-functional teams for defined periods of time.

Interpersonal Skills Ability to interact with other departments within the plant and also members of various teams. Ability to interact effectively with Abbott personnel at other sites within the division. Effective communication and presentation skills.

 

Education and Experience Required:
  • Apprenticeship or Bachelorâs degree in Life Science, Engineering, or closely related discipline is required OR a relevant combination of education or experience.
  • 0-2 years work experience in this job area.
  • Quality or related field experience preferred.
  • Demonstrates basic understanding of regulatory requirements in the healthcare environment

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