Job Description
We are currently looking to fill a Sr Quality Assurance Specialist (Supervisor) position. This position performs and leads activities “on the floor” 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.
Available Work Schedules:
Monday - Friday 2:00pm-10:30pm (2nd shift)
In this role, a typical day might include the following:
Represent Quality Assurance in support of complex and/or significant Deviations, Change Controls, CAPAs, etc., including active participation in investigation, evaluation, and problem resolution
Represents the organization on behalf of QA with external partners to communicate QA policy and procedures; liaise with external partners and provide input on regulatory communication
Train and/or mentor employees, including providing insights and education on processes and procedures, and conveying expectations of QA organization
Provides consultation or advice in alignment with QA policies through a continuous on the floor presence, working with stakeholders by providing QA guidance to events or questions that may arise
Perform activities associated with disposition of product (e.g., manufacturing record review, document review, source data review etc.).
Review, edit, or approve Regeneron controlled documents
Review and approve investigations associated with product or processes
Continually evaluating Regeneron processes and procedures with an eye toward continuous improvement
Supervising direct reports
Participates with employee training to ensure that all requirements are met.
Performs, minimally, monthly performance feedback meetings with direct reports.
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
Can prioritize multiple assignments and changing priorities
Are able to stand for periods of time when performing tasks on the floor
To be considered for this role you must hold a Bachelor’s degree and 6+ years of relevant experience. May substitute proven experience for education requirement.
#REGNQA
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)