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QA Specialist (Operations)

  • Salary: Negotiable
  • Job type: Permanent
  • Location: Limerick
  • Sector: Science
  • Date posted: 05/10/2018
  • Job reference: BBBH89755

QA Specialist (Operations)

My client, an industry leader in Biologics is currently seeking a QA Specialist who will work with dispositioning product and/or raw materials. In this position you will be tasked with all aspects of QA activities while ensuring compliance with QA policies and procedures, cGMPs, SOPs and quality documentation.

Key responsibilities:

  • Represent Quality Assurance in support of complex Deviations, Change Controls, CAPAs, etc., including active participation in investigation, evaluation, and problem resolution.
  • Train and/or mentor junior employees, including providing insights and education on processes and procedures;
  • Provides consultation or advice in alignment with QA policies;
  • Perform activities associated with disposition of raw materials and product (e.g. manufacturing record review, receipt, inspection, document review, shipping, etc). Activities may be on the floor or at a desk.
  • Review and approval of investigations associated with raw materials, product, laboratory, facilities, and materials.
  • Perform status labelling of raw materials and product.

Key requirements

  • Requires BS/BA in scientific discipline or related field and minimum 2 year relevant experience. Relevant experience may be substituted for education requirement.
  • Understanding of biologics manufacturing operations is preferred.
  • Good organizational skills and attention to detail.
  • Requires good written, verbal and interpersonal communication skills and the ability to effectively interact cross functionally.
  • Ability to handle multiple assignments and changing priorities.
  • Ability to learn and utilize computerized systems for daily performance of tasks.
  • Ability to prioritize, manage multiple tasks, and meet deadlines.
  • Ability to work a varied schedule including off shift and weekends.

For more information on this and other similar opportunities please contact Kathryn on 016455250 or email

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