- Reference: CJ46773
- Job Type: Permanent
- Location: Clare, Galway, Limerick
- Category: Bio-Pharmaceutical
Senior Quality Specialist
- 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.
- Deirdre Sheehan
- Senior Technical Recruitment Consultant
- (061) 512271
- Connect with DeirdreLinkedINEmail