QA Specialist - Raw Materials

Rensselaer, NY, United States
Feb 09, 2021
Required Education
Bachelors Degree
Position Type
Full time
We are currently looking to fill a Quality Assurance Specialist position. Regeneron successfully manufactures a range of biopharmaceuticals for patients worldwide, including our approved therapeutic proteins and those involved in clinical studies. Our Quality Assurance Specialists support the disposition of raw materials while ensuring compliance with Quality Assurance policies and procedures, cGMPs, SOPs, and Regeneron Standard Requirement Documents.

As a QA Specialist for Raw Materials, a typical day might include the following:
• Representing Quality Assurance in support of Deviations, Change Controls, CAPAs, etc. including active participation in investigation, evaluation, and problem resolution
• Initiation and/or intake of SCARs (Supplier Corrective Action Requests)
• Providing consultation or advice in alignment with QA policies
• Performing activities associated with disposition of raw materials (e.g. warehouse oversight, receipt, inspection, document review, exception status application/labeling, etc.), activities may be on the floor or at a desk
• Reviewing/editing Regeneron controlled documents
• Supports product-related processes (e.g. bulk shipments, destructions, examinations, vial transfers, etc.)
• Continually evaluating Regeneron processes and procedures with an eye toward continuous improvement

This role might be for you if:
• Excel in a quality driven organization
• Have an understanding of biologics manufacturing operations
• Are organized and have an attention to detail
• Can prioritize multiple assignments and changing priorities
• Are able to learn and utilize computerized systems for daily performance of tasks
• Have interest in/ability to mentor junior employees
• Can work well within a team environment

To be considered for the Quality Assurance Specialist role, you must be willing and able to work 10-hour shifts (4 days per week including 1 weekend day) and you must hold a Bachelor's degree 2+ years of relevant experience for Associate level, 4+ years for Specialist level, 6+ years for Senior level. May substitute proven experience for education requirement. Level is determined based on qualifications relevant to the role.

Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides amazing benefits including health and wellness programs, fitness centers and stock for employees at all levels!

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or maternity status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.