QA Specialist/Sr QA Specialist

QA Specialist/Sr QA Specialist

Regeneron

Limerick, Ireland

Job Description:

Performs activities in support of disposition of product while ensuring compliance with Quality Assurance (QA) policies and procedures, cGMPs, SOPs, and Regeneron Standard Requirement Documents.

As a QA Specialist or Sr QA Specialist a typical day may include the following:

• Preparing & reviewing of batch disposition documentation to support QP release of Formulated Drug Substance
• Reviewing of QC related release data, Documentation review
• Completing deviation, change control & batch record reports to support disposition
• Performing status labelling of product as the need arises
• Representing Quality Assurance in support of deviations, CAPAs, etc.
• Representing the IOPS organisation on behalf of QA with external partners to communicate IOPS QA policy and procedures; liaise with external partners and provide input on regulatory communications
• Training & mentoring employees, including providing insights and education on processes and procedures, and conveying expectations of QA organisation
• Providing consultation or advice in alignment with QA policies Review, edit, or approve controlled documents
• Interacting with various departments to ensure batch release deliverables are met
• Evaluating Regeneron processes and procedures with an eye toward continuous improvement

This role might be for you if:

• You have an understanding of biologics manufacturing operations
• You have excellent organisational skills and attention to detail is essential
• You have good written, verbal and interpersonal communication skills and the ability to optimally interact cross functionally
• You have the ability to prioritise multiple assignments and changing priorities
• You have the ability to learn and utilise computerised systems for daily performance of tasks
• You have the prioritise, manage multiple tasks, and meet deadlines

To be considered for this opportunity you must have a Degree or Masters in a scientific field. For Specialist level 3 years experience is required and Sr Specialist you must have 5+ years experience directly related experience.

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