Sr QA Specialist (Raw Materials)

Rensselaer, New York, United States of America
Jun 19, 2021
Required Education
Bachelors Degree
Position Type
Full time
We are currently looking to fill a Sr Quality Assurance Specialist (Raw Materials) 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.

In this role, 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
• Provides hands on leadership to employees
• Ensures employee timesheets are completed on time
• Participates with employee training to ensure that all requirements are met
• Performs, minimally, monthly performance feedback meetings with direct report
• Raises all performance issues to Manager and/or Directors and/or HR

This role may be for you if you:
• Excel in a quality driven organization
• Have an understanding of biologics manufacturing operations
• Are organized and have an attention to detail
• Have interest in/ability to mentor junior employees
• Are able to lift up to 50 lbs
• Are comfortable working in a warehouse environment 50%

To be considered for the Quality Assurance Specialist role, you must hold a Bachelor's degree and 6+ years of related experience for Senior level. May substitute proven experience for education requirement.

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.