We are currently looking to fill a Quality Assurance Specialist (Batch Disposition) position. This position performs activities supporting dispositioning product and/or raw materials while ensuring compliance with Quality Assurance policies and procedures, cGMPs, SOPs, and Regeneron Standard Requirement Documents.

In this role, a typical day might include the following:

• Representing Quality Assurance in support of sophisticated Deviations, Change Controls, CAPAs, etc., including active participation in investigation, evaluation, and problem resolution

• Participating in cross-functional meetings to achieve standard lead time targets for disposition of drug substance and drug product

• Providing consultation or advice in alignment with QA policies

• Performing activities associated with disposition of raw materials and product (e.g. receipt, inspection, document review, shipping, etc.), activities may be on the floor or at a desk

• Reviewing, editing, or approving Regeneron controlled documents, to include certificates of analysis, manufacturing records, and external partner/contract records

• Participating in investigations associated with raw materials or product

• Performing status labeling of raw materials and product

• Continually evaluating Regeneron processes and procedures with an eye toward continuous improvement

This role may be for you if you:

• Excel in a quality driven organization

• Have an understanding of biologics manufacturing operations, quality control laboratory processes and associated quality systems is preferred

• Possess good written, verbal and interpersonal communication skills and the ability to effectively and comfortably interact cross functionally

• Can prioritize multiple assignments and changing priorities

• Are able to learn and utilize computerized systems for daily performance of tasks

To be considered for this role you must hold a Bachelor’s degree and the following amount of relevant experience for each level:

• Associate QA Specialist – 2 years

• QA Specialist – 4 years

• Sr QA Specialist – 6 years

May substitute proven experience for education requirement. Level is determined based on qualifications relevant to the role.

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