Collins McNicholas

QA Specialist

This role will 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.

Job Description:
• 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.

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 or a confidential discussion contact Deirdre Sheehan on 061-512270 or email deirdre.sheehan@collinsmcnicholas.ie

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