Senior/Quality Specialist - QA

  • Location

    Munster, Republic of Ireland

  • Sector:

    Quality

  • Job type:

    Permanent

  • Salary:

    Up to €0.00 per annum

  • Contact:

    Jack Conway-Kenny

  • Contact email:

    jack.conway-kenny@experis.ie

  • Job ref:

    BBBH100101_1553077157

  • Published:

    9 months ago

  • Expiry date:

    2019-04-19


Senior/Quality Specialist - QA

Summary
My client, a Global Biotechnology company based in the West of Ireland, is looking to expand their Quality team (QA) with a Quality and Senior Quality Specialist due to continued expansion this year. An exciting and hands on role, the successful candidate will perform activities in support of dispositioning product and/or raw materials while ensuring compliance with Quality Assurance (QA) policies and procedures, cGMPs, SOPs, and Regeneron Standard Requirement Documents.

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, edit, or approve Regeneron 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 Regeneron processes and procedures with an eye toward continuous improvement



Key Competencies

  • 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.
  • Ability to work a varied schedule including off shift and weekends.



Education/Experience

  • Requires BS/BA in scientific discipline or related field
  • 5+ years (Senior) relevant experience - GMP
  • Relevant experience may be substituted for education requirement


Interested?
Apply below, or call Jack on 01-6455250 for more information!