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 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 ability to prioritise, manage multiple tasks, and meet deadlines
To be considered for this opportunity you must have a Degree or Masters in a scientific field. Associate Level requires 0-2 years experience, for Specialist level 3 years experience is required and Sr Specialist you must have 5+ years experience directly related experience.
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