Assoc QA Raw Material Specialist

Regeneron Pharmaceuticals•Rensselaer, NY

2d•$62,355 - $92,400•Onsite

About The Position

Performs 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.

Requirements

BS/BA in scientific discipline or related field and minimum 2 years relevant experience
May substitute proven experience for education requirement
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 (Raw Materials)
Ability to work a varied schedule including off shift and weekends
Ability to lift up to 50 pounds (Raw Materials)

Responsibilities

Represent Quality Assurance in support of complex Deviations, Change Controls, CAPAs, etc., including active participation in investigation, evaluation, and problem resolution
Review and approve batch records
Communicate QA policy and procedures; liaise with internal or external partners and stakeholders and provide input on regulatory communications
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. 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 or product
Perform status labeling of product
Adheres to Regeneron processes and procedures and may lead Continuous Improvement initiatives