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!
