QA Specialist (External Filling)

Company: Regeneron Pharmaceuticals, Inc.
Location: Troy
Posted on: January 23, 2023

Job Description:

We are currently looking to fill a Quality Assurance Specialist (External Filling) 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
• Representing the organization on behalf of QA with external partners to communicate QA policy and procedures; liaise with external partners and provide input on regulatory communications
• Training and/or mentoring junior employees, including providing insights and education on processes and procedures
• 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
• 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 improvementThis 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
  • Can prioritize multiple assignments and changing priorities
  • Are able to learn and utilize computerized systems for daily performance of tasksTo 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+ yearsMay 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 comprehensive benefits including health and wellness programs, fitness centers and equity awards, annual bonuses, and paid time off for eligible 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 parental 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.The salary ranges provided are shown in accordance with U.S. law and apply to U.S. based positions, where the hired candidate will be located in the U.S. If you are outside the U.S, please speak with your recruiter about salaries and benefits in your location.Salary Range (annually) $54,400.00 - $117,600.00

Keywords: Regeneron Pharmaceuticals, Inc., Troy , QA Specialist (External Filling), Other , Troy, New York