Onsite
The QA Material Supplier Specialist - Qualification implements activities within the material qualification program to support the utilization of raw materials in Drug Substance and Drug Product Manufacturing.
In this role, a typical day might include the following:
Performing activities associated with qualification of raw materials such as, development of sampling and testing protocols, review of test data, drafting summary reports, etc.; execution of sampling activities may be on the floor
Representing Quality Assurance in support of deviations, change controls, CAPAs, etc. including active participation in investigation, evaluation, and problem resolution
Provides guidance internally and externally to ensure quality and regulatory expectations are met in relation to material quality standards
Support and/or approval of SCARs (Supplier Corrective Action Requests)
Working with Suppliers to obtain documentation to support closure of SCARFs (Supplier Corrective Action Request Follow-Ups)
Reviews/approves Drug Product Component Supplier-specific documentation such as Approved Supplier Approvals and TSE/BSE Assessments
Provides support to relevant departments in the utilization of Drug Product Test Components
Establishing, reviewing, and editing Regeneron controlled documents
Continually evaluating Regeneron processes and procedures with an eye toward continuous improvement; identify gaps in systems and develop feasible plans for correction
This role may be for you if you:
Excel in a quality driven organization
Are an organized individual with attention to detail
Have good written, verbal, and interpersonal communication skills and the ability to effectively interact cross functionally
Can navigate changing priorities
Are able to learn and use computerized systems for daily performance of tasks
Can prioritize, manage multiple tasks, and meet deadlines
Are able to lift up to 25 lbs
Are comfortable working in a warehouse environment 20% of the time
To be considered for this role you must hold a Bachelor’s degree and the following minimum amounts of relevant experience for each level:
QA Material Supplier Specialist – 3+ years
Senior QA Material Supplier Specialist – 5+ years
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 step towards living the Regeneron Way! We have an inclusive culture that provides comprehensive benefits, which vary by location. In the U.S., benefits may include health and wellness programs (including medical, dental, vision, life, and disability insurance), fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves (e.g., military and parental leave) for eligible employees at all levels! For additional information about Regeneron benefits in the US, please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other countries’ specific benefits, please speak to your recruiter.
Please be advised that at Regeneron, we believe we are most successful and work best when we are together. For that reason, many of Regeneron’s roles are required to be performed on-site. Please speak with your recruiter and hiring manager for more information about Regeneron’s on-site policy and expectations for your role and your location.
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. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.
For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.
Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.
Salary Range (annually)
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