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Quality Specialist

Expired
  • Salary: Negotiable
  • Job type: Permanent
  • Location: Munster
  • Sector: Science
  • Date posted: 26/04/2018
  • Job reference: J381763A

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Quality Specialist

Position Summary


Our client, a leading Biopharmaceutical organisation is currently seeking a Quality Specialist to join their expanding team. In this position you would performs activities in support of dispositioning product and/or raw materials while ensuring compliance with Quality Assurance (QA) policies and procedures, cGMPs, SOPs, and Documents.

Essential Duties and Responsibilities include, but are not limited to, the following:

  • 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, edit, or approve controlled documents
  • Review and approval of investigations associated with raw materials, product, laboratory, facilities, and materials.
  • Perform status labeling of raw materials and product


Knowledge, skills, and abilities:

  • Understanding of biologics manufacturing operations is preferred
  • Good organisational 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 utilise computerised systems for daily performance of tasks
  • Ability to prioritise, manage multiple tasks, and meet deadlines
  • Ability to stand for periods of time when performing tasks on the floor.
  • Ability to work a varied schedule including off shift and weekends.

Education and Experience:

  • Requires BS/BA in scientific discipline or related field and minimum 2 year relevant experience. Relevant experience may be substituted for education requirement.

For more information on this and similar position please contact Kathryn on 01 6455244 or email <mailto:>