Senior Quality Specialist

  • Reference: CJ46773
  • Job Type: Permanent
  • Location: Clare, Galway, Limerick
  • Category: Bio-Pharmaceutical

Senior Quality Specialist

Summary:

  • Performs activities in support of dispositioning product and/or raw materials while ensuring compliance with Quality Assurance (QA) policies and procedures, cGMPs, SOPs, and Standard Requirement 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
  • Continually evaluating processes and procedures with an eye toward continuous improvement

Knowledge, skills, and abilities:

  • 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 stand for periods of time when performing tasks on the floor. 

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.


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Deirdre Sheehan

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  • Deirdre Sheehan
  • Senior Technical Recruitment Consultant
  • (061) 512271
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